Job Description Position Summary: Provides administrative guidance and support for the Clinical Systems. Essential functions of the job include but are not limited to: Responsible for internal User Access management request to the Clinical Systems and other business systems. Performs entry of data into the Global Directory within Precisions Clinical System across all Sites, Institutions and update as required. Responsible for the creation of Studies, Countries and Sites within the Clinical System as requested. Addresses help desk tickets assigned to answering questions, trouble shoot problems or identify system performance issues or deficiencies. Supports Clinical System modifications and updates to picklists, field requirements Supports the Clinical teams in the ongoing review of Clinical System access and removal of access as identified or requested. Support the leads or manager in any ad-hoc tasks assigned. Qualifications: Minimum Required: Degree, or equivalent combination of education and experience in information systems or technology Other Required: Preferred: Experience in clinical trial systems (e.g., CTMS, EDC, eTMF and RTMS) with detailed understanding of requirements gathering, documentation, configuration and integrations. Skills: Ability to resolve issues independently with good judgement to escalate appropriately. Ability to learn new systems Strong interpersonal, verbal and written communication skills

Position Summary: The Database Programmer II is responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications. Position will interface directly with the internal team (i.e. Data Management, Project Management, etc.), EDC vendor, clients and third-party vendors to gather requirements and provide status updates. Qualifications: Minimum Required: Must have experience in developing and customizing clinical data management databases in a clinical, scientific or health care discipline 3 years experience in clinical database programming Bachelor s and/or a combination of related experience Medidata Rave EDC Rave API integration experience using external vendor modules Good to have Rave Advanced Custom Function programming experience Other Required: Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of clinical research tasks. Excellent organizational and communication skills Professional use of the English language; both written and oral. Experience in Object Oriented Programming (C#, C++, VBS, etc. ), scripting language (PERL, etc.), SAS, R, SQL Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) Experience in clinical database management system development. Experience in a clinical, scientific or healthcare discipline. Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong leadership and interpersonal skills Must be able to communicate effectively in the English language. Preferred: Oncology and/or Orphan Drug therapeutic experience Base SAS , SAS/STAT and SAS/ACCESS software SAS Macro programming language Advanced experience in Database Management, object-oriented programming Veeva set up experience

Position Summary: The Contracts & Budgets Associate, Site Contract Management, develops and negotiates European study budgets based on the requirements of a study protocol, as well as reviewing, drafting, negotiating and tracking a variety of legal agreements which include confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements. The postholder works closely with the Clinical Operations study team and playing a key role in ensuring deliverables are in alignment with defined study timelines. Essential functions of the job include but are not limited to: Develop, negotiate global study budgets based on the requirements of a study protocol. Review, draft and negotiate a variety of agreements including confidentiality agreements, master. confidentiality agreements, clinical study agreements and amendment agreements Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues Ensure adherence to company policies, procedures and contracting standards. Update relevant study team members regarding the status of contract negotiations and execution. Coordinate execution of agreements Support the maintenance of contract files and databases, including contract archiving. Recognize where processes can be improved and take corrective action. Other tasks, as assigned. Qualifications: Minimum Required: Graduate, postgraduate, 4-year college degree 1 year of relevant experience drafting, reviewing and negotiating agreements related to clinical research i.e. Non-Disclosure Agreements, Clinical Trial Agreements, etc. as well as management, control and tracking of the contract process. Excellent organizational and communication skills and attention to detail. Preferred: Bachelors in law, scientific fields, business administration or equivalent degree Excellent organizational and communication skills and attention to detail Knowledgeable on setting up Contracting Plans - Guides for CTA & Budget negotiations Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines Skills: Competencies Possesses strong organizational/written communication skills and the ability to multi-task and Prioritize in a fast-paced environment. Executes time-sensitive matters while maintaining accuracy and attention to detail. Exhibits high self-motivation and is able to work and plan with some supervision as well as in a global team environment. Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills. Displays sound business judgment and a proactive, independent work style. Is proficient in MS Office software programs and computer applications. Handles sensitive issues with discretion. Works well independently and cooperatively with others to achieve common goals in a virtual environment. Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Position Summary The Operations Specialist I supports a wide range of activities within the Business & Operational Excellence group. Specific tasks depend on the functional area in which the Operations Specialist is aligned, including Resource & Contractor Management, Vendor Management, and Operational Excellence. The Operations Specialist I supports the execution of the functional priorities by supporting leadership in execution of a wide range of tasks and activities. Essential functions of the job include but are not limited to the following as needed: Support in the development of documentation to support processes, procedures, roles and responsibilities Prepare tools and templates as needed to ensure proper execution of processes and procedures Support management of a wide range of materials, ensure tools, templates, process documents are up to date Support communication of new processes to stakeholders Assist in planning, organizing and coordinating specific initiatives Schedule meetings, taking notes, identifying next steps across a range of stakeholders Assist with management of data, spreadsheets, trackers, etc. as needed Help with the onboarding of new contractors, staff, or others as appropriate May travel including overnight travel as needed Qualifications: Minimum Required: BA degree or equivalent regional degree or equivalent combination of education and experience 1-2 years experience with operational support, process improvement or related function Other Required: Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint). Ability to communicate both written and verbal in English with demonstrated proficiency (Business Professional level) Competencies: Demonstrates, or able to learn and retain, a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance. Demonstrates solid interpersonal skills. Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment. Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders. Communicates both verbally and in written form in an efficient and professional manner. Demonstrates values and a work ethic consistent with Precision Values and Company Principles. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Precision for Medicine is seeking a talented Medical Coder to provide comprehensive Coding and related data management support throughout all phases of the clinical trial data management process. With direct supervision work with a team of medical coders, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role encompasses a range of responsibilities, including data coding and quality review within a dynamic team environment . Position Summary: The Coder provides Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full time basis. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives: study specific plans and guidelines will be followed. This position will perform Coding quality reviews. Working closely with the Coding Manager to ensure priority coding tasks are performed and completed in a timely manner Essential functions of the job include but are not limited to: Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency (MedDRA and WHODRUG) Support other members as a back-up and/or coding team member, ensuring continuity, responsiveness,and that tasks are performed in a timely manner Perform quality control of Coding Provide input into Coding timelines for overall deliverables. Ensure that clinical data coding deadlines are met with quality. May assess resource needs for assigned projects, as needed. Review/feedback from all stakeholders Conduct coding dictionary upgrade UAT and maintain quality controlled documentation as needed Responsible for creating, revising, appropriate versioning and maintaining data management coding documentation. Train clinical research personnel on the study specific Coding related items as needed. Review and query coding data according to the Data Management Plan and Coding standards Run coding status and metric reporting. Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to coding activities Trains and ensures that all data management project team members coding have been sufficiently trained. Communicate with study sponsors and project teams as needed regarding coding. Present any coding demonstrations/trainings, department/company training sessions, project meetings Perform other duties as assigned. Qualifications Minimum Required: 4+ years’ experience within Data Management Bachelors within scientific/science background and combination of related experience Other Required: 2+ years performing Dictionary medical coding (MedDRA and WHODrug) Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of data management task and oversight. Excellent organizational and communication skills Professional use of the English language; both written and oral. Basic knowledge of drug, device and/or biologic development and effective data management practices Preferred: Experience in a clinical, scientific or healthcare discipline. Oncology and/or Orphan Drug therapeutic experience Skills: Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary: The Financial Analyst supports the operational project teams financially throughout the life cycle of the project. Essential functions of the job include but are not limited to: Support the project teams in all financial areas associated with running a clinical trial. Assist in the preparation of the monthly invoicing worksheet which is the source document for client invoicing and source of revenue recognition. Support in performing variance analysis comparing forecasted revenue to actual revenue in order to identify gaps, changes in scope, etc. Support in reviewing work orders and change order budgets in comparison with actual activities in order to help identify out of scope activities. Support the monthly project review meetings on an as needed basis. Assist in providing support to the Manager, Operational Finance and Vice President, Operational Finance in the preparation of contract documents (statements of work and change orders). Work with Company Accountant to provide support to the financial reporting and general ledger functions. Work with Company Accountant to provide support to ensure an accurate and timely monthly, quarterly and year-end close Work with Company Accountant to ensure the timely reporting of all monthly financial information. Collaborate with others in Finance to support overall department goals and objectives. Responds to inquiries from the CFO and Vice President, Operational Finance regarding financial results, special reporting requests and ad hoc analyses relating to projects. Assist in development and implementation of new procedures and features to enhance the workflow and internal controls. Qualifications: Minimum Required: Europe: University degree in Accounting/Finance or related field or equivalent experience in accounting discipline North America: Bachelor’s degree in Accounting/Finance or related business discipline. Other Required: 5+ years general ledger and financial reporting experience including working knowledge of all areas of the accounting cycle, project budgets, financial project management support, Earned Value Analysis (“EVA”) analysis, and contract review or equivalent relevant experience and/or demonstrated competencies. Fluency in English and, in addition, for non-English speaking countries the local language of the country where position based. Preferred: CRO industry experience Competencies: Working knowledge of the life cycle of a project with a solid foundation of how the financials and contract status impact each stage of the clinical trial Working knowledge of accounts payable, accounts receivable, general ledger, bank reconciliations, Strong Excel /PC skills and able to thrive in multi-tasking environment Strong accounting skills. High energy and enthusiasm with a strong commitment to exceeding expectations. Flexibility and willing to work on multiple assignments of varying tasks with personnel throughout the organization. Ability to learn quickly. Good oral and written communication & interpersonal skills with the ability to connect and build relationships with management and others throughout the organization. Exhibits self-motivation and is able to work independently as well as in a team environment. Team player with a desire to be an active, long term participant in the growth of the company. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary: The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position may perform database development and testing, as well as additional data management activities. Essential functions of the job include but are not limited to: Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner May perform data entry for paper-CRF studies, as needed May perform quality control of data entry May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation Assist in specifying requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed Review and query clinical trial data according to the Data Management Plan Assist in line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Assist with coordinating SAE/AE reconciliation Assist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department May assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications: Minimum Required: Bachelors and/or a combination of related experience Other Required: 2+ years’ experience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Preferred: Experience in a clinical, scientific or healthcare discipline Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary: The Clinical Data Manager II manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under some supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) and/or contributor for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May perform data entry for paper-CRF studies, as needed May perform quality control of data entry Provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications: Minimum Required: Bachelors and/or a combination of related experience Other Required: 5+ years’ Clinical Data Management experience or demonstrated aptitude in the key skills for the role Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Must be able to read, write, speak fluently and comprehend the English language to enable communication across Precision for Medicine and with clients Experience in utilizing a clinical database management system Broad knowledge of drug, device and/or biologic development and effective data management practices Ability to undertake occasional travel Preferred: Understanding of dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Oncology and/or Orphan Drug therapeutic experience Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary: The Financial Analyst supports the operational project teams financially throughout the life cycle of the project. Essential functions of the job include but are not limited to: Support the project teams in all financial areas associated with running a clinical trial. Assist in the preparation of the monthly invoicing worksheet which is the source document for client invoicing and source of revenue recognition. Support in performing variance analysis comparing forecasted revenue to actual revenue in order to identify gaps, changes in scope, etc. Support in reviewing work orders and change order budgets in comparison with actual activities in order to help identify out of scope activities. Support the monthly project review meetings on an as needed basis. Assist in providing support to the Manager, Operational Finance and Vice President, Operational Finance in the preparation of contract documents (statements of work and change orders). Work with Company Accountant to provide support to the financial reporting and general ledger functions. Work with Company Accountant to provide support to ensure an accurate and timely monthly, quarterly and year-end close Work with Company Accountant to ensure the timely reporting of all monthly financial information. Collaborate with others in Finance to support overall department goals and objectives. Responds to inquiries from the CFO and Vice President, Operational Finance regarding financial results, special reporting requests and ad hoc analyses relating to projects. Assist in development and implementation of new procedures and features to enhance the workflow and internal controls. Qualifications: Minimum Required: Europe: University degree in Accounting/Finance or related field or equivalent experience in accounting discipline North America: Bachelor s degree in Accounting/Finance or related business discipline. Other Required: 5+ years general ledger and financial reporting experience including working knowledge of all areas of the accounting cycle, project budgets, financial project management support, Earned Value Analysis ( EVA ) analysis, and contract review or equivalent relevant experience and/or demonstrated competencies. Fluency in English and, in addition, for non-English speaking countries the local language of the country where position based. Preferred: CRO industry experience Competencies: Working knowledge of the life cycle of a project with a solid foundation of how the financials and contract status impact each stage of the clinical trial Working knowledge of accounts payable, accounts receivable, general ledger, bank reconciliations, Strong Excel /PC skills and able to thrive in multi-tasking environment Strong accounting skills. High energy and enthusiasm with a strong commitment to exceeding expectations. Flexibility and willing to work on multiple assignments of varying tasks with personnel throughout the organization. Ability to learn quickly. Good oral and written communication & interpersonal skills with the ability to connect and build relationships with management and others throughout the organization. Exhibits self-motivation and is able to work independently as well as in a team environment. Team player with a desire to be an active, long term participant in the growth of the company. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionFor . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Position Summary: The Senior Coder provides Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full time basis. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives: study specific plans and guidelines will be followed. This position will perform Coding quality reviews. Working closely with the Coding Manager to ensure priority coding tasks are performed and completed in a timely manner. Working with the Coding manager to focus the medical coders as a senior coder. Essential functions of the job include but are not limited to: Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency (MedDRA and WHODRUG) Support other members as a back-up and/or coding team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner Backup the Coding manager for oversight of the team. Perform quality control of Coding Provide input into Coding timelines for overall deliverables. Ensure that clinical data coding deadlines are met with quality. May assess resource needs for assigned projects, as needed. Review/feedback from all stakeholders Conduct coding dictionary upgrade UAT and maintain quality controlled documentation as needed Responsible for creating, revising, appropriate versioning and maintaining data management coding documentation. Train clinical research personnel on the study specific Coding related items as needed. Review and query coding data according to the Data Management Plan and Coding standards Run coding status and metric reporting. Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to coding activities Trains and ensures that all data management project team members coding have been sufficiently trained. Communicate with study sponsors and project teams as needed regarding coding. Present any coding demonstrations/trainings, department/company training sessions, project meetings Perform other duties as assigned. Qualifications Minimum Required: 5+ years experience within Data Management Bachelors within scientific/science background and combination of related experience Other Required: 5+ years performing Dictionary medical coding (MedDRA and WHODrug) Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of data management task and oversight. Excellent organizational and communication skills Professional use of the English language; both written and oral. Basic knowledge of drug, device and/or biologic development and effective data management practices Preferred: Experience in a clinical, scientific or healthcare discipline. Oncology and/or Orphan Drug therapeutic experience Skills: Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes

Position Summary: The Clinical Data Manager II manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under some supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) and/or contributor for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May perform data entry for paper-CRF studies, as needed May perform quality control of data entry Provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications: Minimum Required: Bachelors and/or a combination of related experience Other Required: 5+ years Clinical Data Management experience or demonstrated aptitude in the key skills for the role Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Must be able to read, write, speak fluently and comprehend the English language to enable communication across Precision for Medicine and with clients Experience in utilizing a clinical database management system Broad knowledge of drug, device and/or biologic development and effective data management practices Ability to undertake occasional travel Preferred: Understanding of dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc. ) Oncology and/or Orphan Drug therapeutic experience Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionFor . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Precision for Medicine is seeking a talented Medical Coder to provide comprehensive Coding and related data management support throughout all phases of the clinical trial data management process. With direct supervision work with a team of medical coders, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role encompasses a range of responsibilities, including data coding and quality review within a dynamic team environment . Position Summary: The Coder provides Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full time basis. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives: study specific plans and guidelines will be followed. This position will perform Coding quality reviews. Working closely with the Coding Manager to ensure priority coding tasks are performed and completed in a timely manner Essential functions of the job include but are not limited to: Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency (MedDRA and WHODRUG) Support other members as a back-up and/or coding team member, ensuring continuity, responsiveness,and that tasks are performed in a timely manner Perform quality control of Coding Provide input into Coding timelines for overall deliverables. Ensure that clinical data coding deadlines are met with quality. May assess resource needs for assigned projects, as needed. Review/feedback from all stakeholders Conduct coding dictionary upgrade UAT and maintain quality controlled documentation as needed Responsible for creating, revising, appropriate versioning and maintaining data management coding documentation. Train clinical research personnel on the study specific Coding related items as needed. Review and query coding data according to the Data Management Plan and Coding standards Run coding status and metric reporting. Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to coding activities Trains and ensures that all data management project team members coding have been sufficiently trained. Communicate with study sponsors and project teams as needed regarding coding. Present any coding demonstrations/trainings, department/company training sessions, project meetings Perform other duties as assigned. Qualifications Minimum Required: 4+ years experience within Data Management Bachelors within scientific/science background and combination of related experience Other Required: 2+ years performing Dictionary medical coding (MedDRA and WHODrug) Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of data management task and oversight. Excellent organizational and communication skills Professional use of the English language; both written and oral. Basic knowledge of drug, device and/or biologic development and effective data management practices Preferred: Experience in a clinical, scientific or healthcare discipline. Oncology and/or Orphan Drug therapeutic experience Skills: Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionFor . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Position Summary The Operations Specialist I supports a wide range of activities within the Business & Operational Excellence group. Specific tasks depend on the functional area in which the Operations Specialist is aligned, including Resource & Contractor Management, Vendor Management, and Operational Excellence. The Operations Specialist I supports the execution of the functional priorities by supporting leadership in execution of a wide range of tasks and activities. Essential functions of the job include but are not limited to the following as needed: Support in the development of documentation to support processes, procedures, roles and responsibilities Prepare tools and templates as needed to ensure proper execution of processes and procedures Support management of a wide range of materials, ensure tools, templates, process documents are up to date Support communication of new processes to stakeholders Assist in planning, organizing and coordinating specific initiatives Schedule meetings, taking notes, identifying next steps across a range of stakeholders Assist with management of data, spreadsheets, trackers, etc. as needed Help with the onboarding of new contractors, staff, or others as appropriate May travel including overnight travel as needed Qualifications: Minimum Required: BA degree or equivalent regional degree or equivalent combination of education and experience 1-2 years experience with operational support, process improvement or related function Other Required: Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint). Ability to communicate both written and verbal in English with demonstrated proficiency (Business Professional level) Competencies: Demonstrates, or able to learn and retain, a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance. Demonstrates solid interpersonal skills. Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment. Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders. Communicates both verbally and in written form in an efficient and professional manner. Demonstrates values and a work ethic consistent with Precision Values and Company Principles. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionFor . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

QuartzBio (www.quartzbio.com) is the Precision Medicine Intelligence Company. Our first-in-class Precision Medicine AI Agent Platform enables autonomous data ingestion and conversational insights across the precision medicine value chain. Powered by a network of domain-specific AI agents, our solutions amplify the efforts of operations, translational, informatics, and IT teams, using AI-driven integration of biomarker, sample, and clinical data to create a unified, scalable data ecosystem. R&D teams can shorten time from data to insights, analytics, and visualizations, accelerating study close and time-to-market. Transform the way precision medicine teams work with 360° intelligence. Position Summary: We are seeking a Business Analyst Manager(Business Intelligence), to guide our strategic decision-making through advanced business intelligence, data analysis, and cross-functional collaboration. This role requires an experienced analyst who is adept at working across teams to identify key Business intelligence product scope opportunities, performs analysis and solution detailing to drive the development of scalable Business intelligence solutions in sample life cycle management and Biomarker data analysis. The ideal candidate brings deep analytical expertise, hands on data analysis skills, a strong understanding of Business intelligence technologies, and the ability to convert ideas to product requirements. You will lead complex analytics initiatives, analyses stakeholder business intelligence requirements, and help enable PDLC (Product development life cycle) process in the analytics workstream. Key Responsibilities: Product Strategy & Feature Management Manage the intake and prioritization of business intelligence product requests. Decompose product requirements into features, and translate them into detailed epics and user stories. Collaborate with product leads to define release scopes and develop product roadmaps. Define and manage business and technical requirements for core BI components and data pipeline initiatives. Technical Analysis & Integration Conduct backend data pipeline analysis to enrich and validate feature requests. Translate complex or ambiguous problems into structured analyses and communicate insights to both technical and non-technical stakeholders. Work closely with AI and intelligent agent teams to integrate BI capabilities with virtual assistants and intelligent systems. Cross-Functional Collaboration Lead product grooming sessions with stakeholders to align on product deliverables. Collaborate with the design team to create user journey maps, wireframes, and other UX deliverables. Partner with engineering teams during sprint demos to review progress and provide product feedback. Define and implement QA processes in collaboration with the QA team to ensure high product quality. Adoption, Enablement & Innovation Drive adoption of business intelligence and semantic layers to empower business users with self-service analytics. Own the full project lifecycle—from scoping and stakeholder alignment to delivery, documentation, and user enablement. Identify opportunities to leverage generative AI to automate insights, enhance reporting, and improve user experience. Continuous Improvement Stay current with BI and analytics trends, tools, and best practices in SaaS environments. Continuously enhance technical skills and remain informed about emerging technologies in the BI space. Qualifications: Bachelor’s degree related field and a minimum of 8 years of relevant work experience in Business and technical analysis tasks related to Business intelligence. 5+ years of experience in Business Analysis, Analytics, or BI roles with increasing levels of responsibility. 4-6 years of experience working in a customer-facing role and leading projects. Advanced proficiency in SQL/MySQL, data visualization tools (e.g., Tableau, Power BI, Looker) , and data modeling concepts. Familiarity with GenAI tools and frameworks (e.g., LangChain, OpenAI, Hugging Face) is a plus. Experience working with modern data stacks (e.g., Snowflake, dbt, Airflow, Redshift, databricks). Experience in clinical operations and Biomarker data analytics (preferred) Excellent problem-solving skills, analytical skills and ability to manage ambiguity with minimal oversight. Excellent communication skills – can tailor messaging to executive, technical, and non-technical audiences. Experience with Agile methodologies and project management tools such as Jira, Confluence, and Asana. Proven leadership in managing complex projects or functional areas, with the ability to balance short-term deliverables and long-term strategic goals. Demonstrated success in leading cross-functional initiatives and mentoring team members. Strong project management skills, including scheduling, budgeting, and status reporting, with a solid understanding of project management processes and tools. Strong written and verbal communication skills. Ability to write complex reports in a clear and concise manner. Provide expertise and guidance to team members. Actively contributes to the development of departmental strategies. Continuously improve technical skills and stay up to date with emerging technologies. Meets budgets and schedules for the entire project lifecycle. Other duties as assigned. Leadership expectations: Follows Company's Principles and code of ethics on a day-to-day basis. Shows appreciation for individual talents, differences, and abilities of fellow team members. Listen and responds with appropriate actions. Supports change initiatives and continuous process improvements. Communicates effectively and appropriately with colleagues, supervisors and clients. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Job Description Position Summary: Provides administrative guidance and support for the Clinical Systems. Essential functions of the job include but are not limited to: Responsible for internal User Access management request to the Clinical Systems and other business systems. Performs entry of data into the Global Directory within Precisions Clinical System across all Sites, Institutions and update as required. Responsible for the creation of Studies, Countries and Sites within the Clinical System as requested. Addresses help desk tickets assigned to answering questions, trouble shoot problems or identify system performance issues or deficiencies. Supports Clinical System modifications and updates to picklists, field requirements Supports the Clinical teams in the ongoing review of Clinical System access and removal of access as identified or requested. Support the leads or manager in any ad-hoc tasks assigned. Qualifications: Minimum Required: Degree, or equivalent combination of education and experience in information systems or technology Other Required: Preferred: Experience in clinical trial systems (e.g., CTMS, EDC, eTMF and RTMS) with detailed understanding of requirements gathering, documentation, configuration and integrations. Skills: Ability to resolve issues independently with good judgement to escalate appropriately. Ability to learn new systems Strong interpersonal, verbal and written communication skills Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary: The Senior Medical Writer (MW) will be responsible for leading the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete MW activities with impeccable attention to detail. Essential functions of the job include but are not limited to: Planning, writing, editing, formatting, and QC review of timely and high-quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements based on regulatory guidances Ensures smooth and effective document management from start to finish (ie, from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments Ability to independently formulate key messages from clinical study data Ability to author complex content using knowledge/skills and understanding of processes Ability to communicate clearly and concisely both in writing and verbally with internal and client teams Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents Excellent problem-solving skills, performing literature-based research to support writing activities Qualifications: Minimum Required: BS degree or equivalent in a scientific or medical discipline with relevant writing expertise 5+ years of experience as a medical writer in the sponsor and/or CRO setting Other Required: Proficiency with Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint Clear understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, EudraCT, CT.gov), and eCTD requirements for all phases of development Impeccable attention to detail and ability to complete writing assignments in a timely manner Ability to work effectively in a fast-paced environment with multiple high priority projects with no instruction on routine work and minimal instruction on new assignments Preferred: Advanced degree (MS/PhD) Oncology and/or rare disease experience (especially protocol and CSR development. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Job Summary: We are seeking a detail-oriented Data Analyst to join our team in India. This hybrid role involves managing time transfers of billable employee hours between projects, ensuring accurate data entry and timely updates. The specialist will also handle the integration of time data from various business groups into our ERP system. Key Responsibilities: Time Transfers: Process time transfers of billable employee hours between projects once approved by project managers. Data Integration: Upload time data from business groups not in our ERP system into the ERP system to ensure accurate booking against projects. Data Accuracy: Ensure all data entered is accurate and up to date, maintaining high standards of data integrity. Reporting: Generate and distribute reports related to time entries and transfers as required. Communication: Collaborate with project managers and business groups to resolve any discrepancies or issues related to time entries. Documentation: Maintain detailed records of all time transfers and data uploads for auditing and reference purposes. Support: Provide support to the operations team with other data entry tasks as needed. Requirements: Education: Bachelors degree in business administration, Operations Management, Accounting or Finance or a related field. Experience: 0-2 years of experience in data entry or operations roles, preferably in a corporate environment. Skills: Attention to Detail: Exceptional accuracy and attention to detail in data entry. Analytical Skills: Ability to analyze data and identify discrepancies. Communication: Strong verbal and written communication skills. Technical Proficiency: Familiarity with ERP systems and proficiency in Microsoft Office Suite (Excel, Word, etc.). Time Management: Ability to manage multiple tasks and meet deadlines. Team Player: Collaborative attitude and ability to work effectively in a team environment. Tec hnical Proficiency: Proficient in Microsoft Office Suite, with strong Excel skills including formulas (e.g., VLOOKUP, IF, SUMIFS), pivot tables, and data validation. Familiarity with ERP systems is a plus. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Position Summary: The Central Monitor II will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study KRIs (in collaboration with Functional leads), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings. works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, the Central Monitor II may mentor junior colleagues, and may support the development of processes, procedures and other documentation to ensure a high functioning team Essential functions of the job include but are not limited to: Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance. RBQM Meetings: support monthly RBQM meetings by supporting review of study data, documenting findings, action plans and coordination of data cleaning activities to support study deliverables Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation Qualifications: Minimum Required: Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience Minimum 2 years experience in clinical monitoring, clinical trial management or equivalent Working knowledge of ICH GCP guidelines and the clinical development process Other Required: Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Excellent written and spoken English, including strong grammar and scientific vocabulary skills Ability to work in a team or independently as required Strong understanding of RBQM principles and methodologies. Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Proficiency in statistical analysis and data monitoring tools. Detail-oriented with strong analytical and problem-solving skills Preferred: CRO experience as a Central Monitor Skills: Statistical analysis and data monitoring Risk assessment and mitigation Report writing and presentation Collaboration and teamwork Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

Position Summary: The Principal Central Monitor serves as a strategic leader in driving data integrity, patient safety, and operational excellence across clinical development programs through advanced centralized monitoring and risk-based quality management (RBQM). This role is accountable for shaping and executing enterprise-wide RBQM strategies, leading complex risk assessments, and defining key risk indicators (KRIs) in collaboration with senior functional leaders. Operating at the highest level of subject matter expertise, the Principal Central Monitor oversees the design and implementation of centralized statistical monitoring frameworks, leads RBQM governance forums, and ensures proactive risk detection and mitigation across portfolios. This role provides strategic oversight for high-impact studies and therapeutic areas, guiding cross-functional teams through data-driven decision-making and continuous improvement. In addition to managing escalations and complex data review activities, the Principal Central Monitor mentors senior & junior colleagues, contributes to global process innovation, and plays a key role in shaping policies, tools & technologies that enhance centralized monitoring capabilities organizationally. Essential functions of the job include but are not limited to: Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's needs - including identification of critical data & process, definition of KRIs & QTLs and centralized monitoring approach Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM Advanced Centralized Statistical Monitoring: Design and oversee the implementation of advanced centralized statistical monitoring frameworks. Interpret complex data patterns, lead root cause analyses, and drive data-driven decision-making to enhance study quality and compliance, in collaboration with functional team leads and PM RBQM Meetings: Lead facilitation monthly RBQM meetings, bringing together key stakeholders to review and discuss study data, findings, action plans and coordination of data cleaning activities to support study deliverables. Drive the review of key risk indicators (KRIs), data trends, and issue resolution plans. Provide expert guidance on data cleaning prioritization to meet critical study milestones. Data Quality Assurance and Oversight: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. Mentor teams on proactive data monitoring techniques and lead initiatives to continuously improve data integrity and efficiency. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. Translate complex monitoring insights into actionable recommendations that drive strategic decisions and study success. Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation Mentor and Support Junior Colleagues: Act as a mentor to more junior Central Monitors - sharing best practices, lessons learned, etc. to improve team performance Sponsor Engagement and Communications: lead discussions with Sponsors around risk management and proactive data cleaning Qualifications: Minimum Required: Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience Minimum 8 years experience in clinical monitoring, clinical trial management or equivalent Working knowledge of ICH GCP guidelines and the clinical development process Other Required: Highly effective oral and written communication skills with the ability to communicate effectively with project team members Excellent organizational and time management skills Excellent written and spoken English, including strong grammar & scientific vocabulary skills Ability to work in a team or independently as required Strong understanding of RBQM principles and methodologies. Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk Proficiency in statistical analysis and data monitoring tools. Detail-oriented with strong analytical and problem-solving skills Demonstrated experience with integrated risk planning & management Ability to mentor junior team members Preferred: CRO experience as a Central Monitor Skills: Statistical analysis and data monitoring Risk assessment and mitigation Report writing and presentation Collaboration and teamwork Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. 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