Responsible for assisting Project Management personnel with various tasks throughout the study lifecycle. ESSENTIAL DUTIES AND RESPONSIBILITIES: Assist with the Planning and Setup, Monitoring, and Closeout Phases of study management which may include: Database setup. Study documentation development. Equipment distribution/tracking. Report creation/distribution. Archival of study documentation. Coordinate Project Assurance meetings and assist with compiling meeting minutes and action items. Support financial components of study management including: Assistance with documentation/database updates due to scope changes. Follow-up related to invoice reconciliations. Preparation of reports in support of study forecasting activities. Facilitate issue management by documenting and tracking progress to ensure timely resolution to customer escalations. OTHER DUTIES AND RESPONSIBILITIES: Ensure compliance with timely training completion/documentation. Respond to customer inquiries and participate in customer calls/meeting upon Project Manager s request. Take the lead in managing various aspects of a project as requested. Other related projects and tasks as assigned. QUALIFICATIONS AND SKILLS NEEDED: Education : Bachelor Degree preferred. Experience : At least 1-3+ years of experience in pharmaceutical field (or related industry experience). Knowledge of the drug development process. Good organizational, interpersonal, time management, and prioritization skills Excellent verbal and written communication skills, including ability to communicate effectively in English. Detail oriented and responsive to inquiries and requests. Working knowledge of Microsoft Office products. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Are you seeking a purposeful and rewarding commercial RFI & Content career opportunity within the Clinical Research industry? Our operations in India are growing, and with big ambitions and a clear vision for the future, now is the time to join Clario s global team as an RFI & Content Analyst. What we offer Competitive compensation (fixed + variable) Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing RFI/RFQ Management Process RFI/RFQ requests through the Clario proposal response system, including but not limited to, site and device qualification forms Review responses suggested by the system for relevancy and update where necessary Investigate technical specification documentation, user manuals etc. to obtain information as required Liaise with internal SMEs to obtain information as required Ensure the timely and accurate delivery of all deliverables Database Management Management of the RFI content library Maintain accuracy of responses in the RFI content library Manage RFI/RFQ requests in Salesforce Manage the systematic SME review of stock answers through the system Manage library of SME responses within the system Internal Relationship Management Manage interactions with SMEs relating to detail gathering for RFI/RFQ through the system Manage communication, updates and expectations of Project Management and other internal requestors as required Contributes to team effort by Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Supporting other functional teams with any information request needs Perform other duties as assigned What we look for Bachelor s degree, or minimum years experience required as outlined below Knowledge of Salesforce or similar CRM tool required Microsoft Office applications including Excel, Word and Access required RFI/RFQs and/or content management tools experience desirable 2+ years experience in Project or Proposal Management/Co-ordination, Relationship Management/Account Management, liaising with multi-departmental stakeholders 2+ years relevant industry experience preferred Ability to work independently or in team setting; ability to adjust to changing priorities Excellent attention and orientation toward meticulous work Strong organization skills and ability to prioritize and meet deadlines Strong interpersonal and communication skills, both verbal and written Ability to project and maintain a professional and positive attitude . EEO Statement .

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as an Assistant Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Assists Clinical Project Managers with project administration by: Developing project related documents Reviewing and editing project presentations Participating in project meetings, conference calls, and training calls Reading and understanding project protocol documents Acting as a liaison with cross-functional team members to ensure timely completion of all study deliverables. Reporting study needs and issues Supporting overall project start-up, execution and close out activities Supporting project finance-related activities such as: Assistance with documentation / database updates due to project scope changes Follow-up related to invoice reconciliations. Preparation of project reports in support of project forecasting activities Assists Clinical Project Managers in maintaining, reviewing, and communicating project progress by: Monitoring internal data flow to ensure completion of tasks within agreed upon timeframes Responding to inquiries in a professional, courteous, and timely manner Communicating with clients regarding project status Verifying protocol imaging requirements are met and queries appropriately identified Serving as acting Project Manager in the absence of the assigned Project Manager Creating, reviewing, and distributing (internally and/or externally) project report(s) Ensures the development and adherence to project timelines by: Following up on outstanding items including missing data, incomplete paperwork, queries, etc. Assisting in tracking and resolving of client issues Serving as additional point of contact to client, sites, sponsors, etc. Supporting Logistics with the distribution, management and tracking of site-facing materials Keeping clinical project manager(s) (CPM) and supervisor advised of current issues Maintains Quality Service and Departmental Standards by Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) Executing technical and clinical functions as required by the study protocol in accordance with Clario s GCP s, ICH and FDA Guidelines. Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives. What we look for Bachelor s Degree preferred 1 + years of experience working in pharmaceutical drug development, clinical trials, and/or clinical research preferred Strong experience with and knowledge of the Microsoft Office suite of software productivity tools Healthcare, medical experience, and/or clinical research, preferred Strong organizational, interpersonal, time management, and prioritization skills Excellent interpersonal, verbal and written communication skills, including ability to communicate effectively in English Detail oriented, meticulous, and responsive to inquiries and requests Ability to work independently, and to collaborate in a team setting Ability to deal with uncertainty, and adapt to changing priorities Pragmatic, proactive and goal oriented Ability to project and maintain a professional and positive attitude. .

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as an Assistant Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Assists Clinical Project Managers with project administration by: Developing project related documents Reviewing and editing project presentations Participating in project meetings, conference calls, and training calls Reading and understanding project protocol documents Acting as a liaison with cross-functional team members to ensure timely completion of all study deliverables. Reporting study needs and issues Supporting overall project start-up, execution and close out activities Supporting project finance-related activities such as: Assistance with documentation / database updates due to project scope changes Follow-up related to invoice reconciliations. Preparation of project reports in support of project forecasting activities Assists Clinical Project Managers in maintaining, reviewing, and communicating project progress by: Monitoring internal data flow to ensure completion of tasks within agreed upon timeframes Responding to inquiries in a professional, courteous, and timely manner Communicating with clients regarding project status Verifying protocol imaging requirements are met and queries appropriately identified Serving as acting Project Manager in the absence of the assigned Project Manager Creating, reviewing, and distributing (internally and/or externally) project report(s) Ensures the development and adherence to project timelines by: Following up on outstanding items including missing data, incomplete paperwork, queries, etc. Assisting in tracking and resolving of client issues Serving as additional point of contact to client, sites, sponsors, etc. Supporting Logistics with the distribution, management and tracking of site-facing materials Keeping clinical project manager(s) (CPM) and supervisor advised of current issues Maintains Quality Service and Departmental Standards by Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) Executing technical and clinical functions as required by the study protocol in accordance with Clario s GCP s, ICH and FDA Guidelines. Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives. What we look for Bachelor s Degree preferred 1 + years of experience working in pharmaceutical drug development, clinical trials, and/or clinical research preferred Strong experience with and knowledge of the Microsoft Office suite of software productivity tools Healthcare, medical experience, and/or clinical research, preferred Strong organizational, interpersonal, time management, and prioritization skills Excellent interpersonal, verbal and written communication skills, including ability to communicate effectively in English Detail oriented, meticulous, and responsive to inquiries and requests Ability to work independently, and to collaborate in a team setting Ability to deal with uncertainty, and adapt to changing priorities Pragmatic, proactive and goal oriented Ability to project and maintain a professional and positive attitude. .

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as a Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Identifies project guidelines and communication needs by: Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents Defining project plans (i.e. timelines, milestones and limitations for project staff) Establishing project reporting schedules Providing project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on schedule Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s) Performs project analysis and management by: Identifying critical project success factors for tracking, analysis and reporting Determining needed resources for project completion and communicating needs to appropriate departmental managers Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting Understanding SOPs and working closely with QA for clarification and documentation of deviations Training and maintaining project team knowledge and applications of SOPs Communicating all protocol clarifications/revisions to project team Coordinating site management of data collection with internal and external teams Provides project team leadership by: Leading by example with professional and collaborative conduct Developing and delivering team project training Establishing team performance expectations and guidelines Providing input to departmental managers of respective team members performance level Analyzing team performance for consistency/quality within established project guidelines Collaborating with the departmental managers for team coaching/mentoring Supports Business Development efforts by: Collaborating with BD Director in the development and presentation of company capabilities calls/meetings Attending professional meeting(s) as Company representative Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services Oversees project close out by: Assisting with coordination of submission activities, as applicable Assisting with initiating and overseeing all project close out activities to completion Performs supervisory functions by, if applicable: Communicating job expectations Planning, monitoring and appraising job results Coaching, counseling and disciplining staff Initiating, coordinating and enforcing systems, policies and procedures Approving direct reports time sheets, requests for time off and/or overtime Performing timely performance evaluations of direct reports Coordinating and conducting new hire interviews; facilitating hiring decision Training new hires on departmental processes and responsibilities Maintains Quality Service and Departmental Standards by: Reading, understanding and adhering to organizational Standard Operating Procedures ( SOP ) Establishing and enforcing departmental standards Reviewing and updating company SOPs related What we look for Bachelor s degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable Previous management or project experience in clinical development of investigational medications required 3 + years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role. Working knowledge of GCH, ICH guidelines and FDA regulations Medical Imaging experience a plus Experience working with computer software including Word, Excel, Access and Project preferred Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal oriented Ability to maintain professional and positive attitude .

Primary Responsibilities Experience in writing complex SQL queries and experience with any data visualization tool is preferable e.g., Tableau, Power BI. Good exposure of Software Testing methodologies, Implementation of Data Lakes, Data warehouse/ETL projects , Big Data projects in On-Premises & Cloud Environments Experienced in SAS applications and Python Programming Ability to write SQL queries to conduct data validations and probe quality issues with data. Experience in Project Delivery Methodologies: SDLC, Iterative, Agile, Scrum, Kanban Experience in ALM Tools like JIRA, TFS (Azure Devops) & Confluence. Knowledge on data quality fundamentals and data governance concepts. Hands-on experience with all levels of testing includes Smoke Testing, Integration Testing, System Testing and Regression Testing. Knowledge of PL-SQL, PySpark & SQL, on framing and tuning the Queries so that it covers all the data scenarios. Accountable for high quality and on time delivery for task assigned. Qualifications: Education: Bachelor s degree required in computer sciences, or equivalent and relevant work experience in a software Testing environment. Experience: Around 3 to 6 years of experience in Software Quality Testing. Prior testing experience with pharmaceutical related software, preferred. In-depth understanding of software quality assurance, preferably in a Clinical Data environment. Ability to write SQL queries to conduct data validations and probe quality issues with data. Experience in Project Delivery Methodologies: SDLC, Iterative, Agile, Scrum, Kanban Knowledge and understanding of the Software Development, Life Cycle (SDLC) testing methodology and document management. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) Experience in writing test cases based on product requirements. Experience working closely with development and business teams to communicate problem impacts and to understand business requirements. Shows creativity and initiative to improve product test coverage and effectiveness (preferred)

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as an Assistant Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Assists Clinical Project Managers with project administration by: Developing project related documents Reviewing and editing project presentations Participating in project meetings, conference calls, and training calls Reading and understanding project protocol documents Acting as a liaison with cross-functional team members to ensure timely completion of all study deliverables. Reporting study needs and issues Supporting overall project start-up, execution and close out activities Supporting project finance-related activities such as: Assistance with documentation / database updates due to project scope changes Follow-up related to invoice reconciliations. Preparation of project reports in support of project forecasting activities Assists Clinical Project Managers in maintaining, reviewing, and communicating project progress by: Monitoring internal data flow to ensure completion of tasks within agreed upon timeframes Responding to inquiries in a professional, courteous, and timely manner Communicating with clients regarding project status Verifying protocol imaging requirements are met and queries appropriately identified Serving as acting Project Manager in the absence of the assigned Project Manager Creating, reviewing, and distributing (internally and/or externally) project report(s) Ensures the development and adherence to project timelines by: Following up on outstanding items including missing data, incomplete paperwork, queries, etc. Assisting in tracking and resolving of client issues Serving as additional point of contact to client, sites, sponsors, etc. Supporting Logistics with the distribution, management and tracking of site-facing materials Keeping clinical project manager(s) (CPM) and supervisor advised of current issues Maintains Quality Service and Departmental Standards by Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) Executing technical and clinical functions as required by the study protocol in accordance with Clario s GCP s, ICH and FDA Guidelines. Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives. What we look for Bachelor s Degree preferred 1 + years of experience working in pharmaceutical drug development, clinical trials, and/or clinical research preferred Strong experience with and knowledge of the Microsoft Office suite of software productivity tools Healthcare, medical experience, and/or clinical research, preferred Strong organizational, interpersonal, time management, and prioritization skills Excellent interpersonal, verbal and written communication skills, including ability to communicate effectively in English Detail oriented, meticulous, and responsive to inquiries and requests Ability to work independently, and to collaborate in a team setting Ability to deal with uncertainty, and adapt to changing priorities Pragmatic, proactive and goal oriented Ability to project and maintain a professional and positive attitude. .

Lead Data Manager - ERT Legacy In addition to ensuring high quality data is provided to the Sponsors, the Lead Data Manager takes an active role in developing employees by providing mentoring and training on Clario processes and systems, and oversight and support to ensure DM staff successfully perform their daily duties. ESSENTIAL DUTIES AND RESPONSIBILITIES: Oversee assigned team: Direct the hiring, orientation, and training for the Clinical Data Management team members. Perform routine employee evaluations. Mentor and develop employees to prepare them for future growth opportunities within the company. Provide mentoring and organize training on new equipment, processes, or systems, including new hire orientation and introduction. Organize the process to ensure that the team s data management files are current and complete. Support routine status meetings with Sponsor/CRO and internal teams for your staff. Monitor the productivity and quality of the Clinical Data Management team: Develop method to track and report key quality indicators, productivity, successful data delivery, and query metrics. Conduct routine reviews with Managers, Supervisors and staff on production and key quality indicators. Support the assigned employees in setup of edit checks and proper auctioning of edit check output Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns. Define the Data Management Plan (DMP) through collaboration with clients, Project Management and Account Management. Through interactions with the Sponsor and Clinical Data Programming department, provide support to the DM team members in development, review, and finalization of data transfer requirements. Ensure the quality of study set-ups by participating in the review and approval process for all Data Management owned modules. Ensure high customer satisfaction by delivering on promises, meeting timelines, and providing excellent customer service at all times. Assist in the preparation of monthly reporting by providing metrics as required Develop, review and revise Standard Operating Procedures, Standard Work Instructions, Job Descriptions, and Departmental Training as needed. Create and or/review and approve SOPs and SWIs to ensure best practices are defined and followed during the lifecycle of a study. Assist Business Development and Quality Assurance with internal and external client meetings and audits and support Clinical Data Management team at such meetings. OTHER DUTIES AND RESPONSIBILITIES: Support clear and effective communication with Sponsor and other Clario departments in the single projects (e.g. Project status, timelines, etc.) Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation Job Profile Job Description Lead in resolving Quality Event issues related to study-specific data management activities Work with the Director to develop training programs Administer training as needed QUALIFICATIONS AND SKILLS NEEDED: Education : BS/BA degree in Life Sciences or related field preferred Experience : 5 + years Data Management related experience Prior leadership experience a plus Proficient in Microsoft Office applications Strong organizational, interpersonal, time-management, and problem-solving skills with good leadership abilities Ability to manage multiple priorities Strong attention to detail Previous SAS or SQL exposure or experience a plus Excellent communication skills and ability to work well with others Ability to communicate effectively in English We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

BASIC PURPOSE:To manage the completion of administrative tasks required in the day-to-day operation of the Client Education team. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1) Manage the purchase and invoicing process for any costs incurred during the development of client training or operational management of the Client Education team. This includes: Identify budget required for cost Initiate purchase order Review and approve invoices Update study budget files accordingly 2) Monitor and report on expenses related to consultant use to conduct live training 3) Prepare and deliver any reports requested or contracted for clients 4) Oversee the invoicing for any client training deliverables. 5) Manage the software and device distribution and costs for the Client Education team. 6) Maintain and support any automation or databases used by the Client Education team. QUALIFICATIONS AND SKILLS NEEDED: (Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.) Education : Associates degree or equivalent in business administration, finance, or human resources Experience : 3-4 years of experience in similar job position Strong organization and time-management skills, and attention to detail Excellent verbal and written communication and interpersonal skills Independent working Working conditions: Other: Computer work for long periods of time

Responsible for assisting Project Management personnel with various tasks throughout the study lifecycle. ESSENTIAL DUTIES AND RESPONSIBILITIES: Assist with the Planning and Setup, Monitoring, and Closeout Phases of study management which may include: Database setup. Study documentation development. Equipment distribution/tracking. Report creation/distribution. Archival of study documentation. Coordinate Project Assurance meetings and assist with compiling meeting minutes and action items. Support financial components of study management including: Assistance with documentation/database updates due to scope changes. Follow-up related to invoice reconciliations. Preparation of reports in support of study forecasting activities. Facilitate issue management by documenting and tracking progress to ensure timely resolution to customer escalations. OTHER DUTIES AND RESPONSIBILITIES: Ensure compliance with timely training completion/documentation. Respond to customer inquiries and participate in customer calls/meeting upon Project Manager s request. Take the lead in managing various aspects of a project as requested. Other related projects and tasks as assigned. QUALIFICATIONS AND SKILLS NEEDED: Education : Bachelor Degree preferred. Experience : At least 1-3+ years of experience in pharmaceutical field (or related industry experience). Knowledge of the drug development process. Good organizational, interpersonal, time management, and prioritization skills Excellent verbal and written communication skills, including ability to communicate effectively in English. Detail oriented and responsive to inquiries and requests. Working knowledge of Microsoft Office products.

Work with team members to ensure both company and department SOPs and Working Practices are being followed. Ensure protocol compliance according to documented protocol requirements. Conduct initial training of all new team members. Maintain production and quality metrics for team members. Direct the daily workflow of the team by monitoring queues and work assignments to ensure all team tasks are completed daily. ESSENTIAL DUTIES AND RESPONSIBILITIES: This position requires a minimum of 50% of the employee s time be spent performing operational tasks outlined below: Investigates and issues queries to sites/sponsors to verify/obtain demographic and visit information on ECGs, Holters and Flashcards/Transmittal Forms. Investigates and enters resolutions received from Data Clarification Requests. Maintains accurate and complete Data Coordination files for all resolutions received, including filing signed DCFs and Data Revision Request Forms in protocol and/or investigator folders. Investigates and performs Self Evident Corrections as outlined in the SEC Guidelines in the Data Coordination System Independent SWI or documented in the PRS. Performs revisions received on Data Revision Request Forms for EXPeRT Attends Project Assurance meetings and outlines feedback to Data Coordination via email. Maintains minimum departmental metrics. Assists with the Data Entry, Scanning and Barcoding procedures for the Data Acquisition team. OTHER DUTIES AND RESPONSIBILITIES: The remaining 50% of the employee s time will be allocated as follows: Monitors daily workflow of the Data Coordination and Data Acquisition Team. Maintains an accurate assessment of existing and projected workload and expected timelines. Ensures equal distribution of work to all team members. Adjusts team member assignments as required to maintain operational efficiencies. Training : Trains new staff in the daily operations of the Data Coordination Department. Assists in performing the 6 month evaluations for all new Data Coordination members. Provides feedback through routine one-on-one meetings and writes performance reviews for all Data Coordinators. Maintains daily communication between shifts. Communicates any issue that will need follow-up on another shift Communicates deadlines: Keeps all shifts adequately informed about procedure changes and workload demands. Assists in the development and maintenance of department SOPs and Working Practices. Prepares client activity metrics (paper ECGs received and processed, queries received and resolved, etc.) and any specific information regarding problematic accounts for presentation and discussion at Client Meetings. Attends, or sends a delegate to, all planning meetings. Record and distribute information relative to Data Coordination activities to the team. Present Data Coordination issues. Mentors Data Coordinators on the nuances of query resolution and issuance, including wording queries to sites/sponsor, researching issues through EXPeRT systems and the Data Cleaning Application. Oversee the daily functions of the query department to ensure that metric goals are being achieved. Track and monitor employee productivity and quality metrics. Coach DCs and DAA to achieve and exceed targets. Ensure all procedures and processes outlined in global SOPs and SWIs are adhered to. Provide training on updated SOP/SWI and system enhancements as appropriate. Ensure accurate and timely collection of demographic and visit data. Maintain workflow to meet turnaround time requirements by monitoring system queues and reports as necessary. Conduct monthly individual and team meetings to review metrics, upcoming or outstanding work and both individual and departmental goals and objectives. Report to management the conduct, efficiencies and metrics for staff performance. QUALIFICATIONS AND SKILLS NEEDED: (Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.) Education : BS or BA degree in life sciences or related field or 3-5 years departmental or related experience. Experience : Strong investigational and documentation skills. Positive mentor to new and existing team members with ability to motivate co-workers. Detail oriented, with ability to prioritize. Ability to adapt to shifting demands. Excellent organizational, communication and computer skills. Good presentation skills.

Are you seeking a purposeful and rewarding Project Management career opportunity within a team dedicated to specialty solutions for clinical trials Our Clinical Adjudication team is expanding in India, and with ambitious goals and a clear vision for the future, now is the perfect time to join Clario as a Clinical Project Manager. In this role, you will be part of a team dedicated to ensuring unbiased and standardized evaluation of clinical trial events, contributing to the credibility and success of our studies. Join us and make a meaningful impact in the field of clinical research. What we offer Competitive compensation + shift allowances Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Identifies project guidelines and communication needs by: Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents Defining project plans (i.e. timelines, milestones and limitations for project staff) Establishing project reporting schedules Providing project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on schedule Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s) Performs project analysis and management by: Identifying critical project success factors for tracking, analysis and reporting Determining needed resources for project completion and communicating needs to appropriate departmental managers Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting Understanding SOPs and working closely with QA for clarification and documentation of deviations Training and maintaining project team knowledge and applications of SOPs Communicating all protocol clarifications/revisions to project team Coordinating site management of data collection with internal and external teams Provides project team leadership by: Leading by example with professional and collaborative conduct Developing and delivering team project training Establishing team performance expectations and guidelines Providing input to departmental managers of respective team members performance level Analyzing team performance for consistency/quality within established project guidelines Collaborating with the departmental managers for team coaching/mentoring Supports Business Development efforts by: Collaborating with BD Director in the development and presentation of company capabilities calls/meetings Attending professional meeting(s) as Company representative Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services Oversees project close out by: Assisting with coordination of submission activities, as applicable Assisting with initiating and overseeing all project close out activities to completion Performs supervisory functions by, if applicable: Communicating job expectations Planning, monitoring and appraising job results Coaching, counseling and disciplining staff Initiating, coordinating and enforcing systems, policies and procedures Approving direct reports time sheets, requests for time off and/or overtime Performing timely performance evaluations of direct reports Coordinating and conducting new hire interviews; facilitating hiring decision Training new hires on departmental processes and responsibilities Maintains Quality Service and Departmental Standards by: Reading, understanding and adhering to organizational Standard Operating Procedures ( SOP ) Establishing and enforcing departmental standards Reviewing and updating company SOPs related What we look for Bachelor s degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable Previous management or project experience in clinical development of investigational medications required 1-3 years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role. Working knowledge of GCH, ICH guidelines and FDA regulations Clinical Adjudication experience a plus Experience working with computer software including Word, Excel, Access and Project preferred Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal oriented Ability to maintain professional and positive attitude

Clario s medical imaging expertise is unparalleled in the industry. With over 30 years of experience, we provide seamless, secure, and compliant medical imaging solutions that optimize clinical trials. Our commitment to excellence has made us a leader in the medical imaging core lab sector. We are seeking dedicated and skilled Medical Imaging Technologists to join our growing operations team in India. What we offer Competitive compensation (fixed + variable) Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Our Medical Imaging Technologists ensure Quality, including Protocol Compliance and Technical Adequacy, of Image Data by: Reviewing and analysing image data for clarity and quality Verifying image data is in compliance with project protocol requirements Generating image queries when needed Working with therapeutic team to notify Sponsor/Site for proper resolution of quality issues Assisting in archiving data for completed projects Performs other image analysis functions as may be required by: Performing client or internal demonstrations of image processing Reviewing and preparing images for submission to client and/or agency Identifies and communicates Project Requirements as they relate to the image quality review (IQR) processes by Reviewing evaluations of potential clinical research sites and verifying the accuracy of information pertaining to site personnel, medical imaging equipment, imaging protocol and data archival capabilities Providing support for technical imaging related issues Performing study initiation/technical visits to educate site personnel on image acquisition protocol, data archival, and data transmittal procedures including form(s) completion Assisting in the design and implementation of study related forms Assisting in writing and reviewing imaging guidelines/manuals Assisting in reviewing Site Surveys Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) Assisting in establishing and enforcing departmental standards Participating in user acceptance testing for new tools and software enhancements Participating in the modification of company SOPs related to IQR What we look for Bachelor s degree preferred 2+ years as Imaging Technologist in a imaging center or relevant clinical trial experience preferred Experience with PET is preferred Experience with X-Ray, MRI & CT modalities advantageous Experience working with computer software including Word, Excel and Access preferred Experience working with clinical trials and/or within pharmaceutical environment preferred Individuals who are able to work remotely and open to European and US time zone working hours

Are you a problem solver? Do you like figuring out how things work and talking with others to share your knowledge? Would you like to work in an international team? Clario partners with the pharmaceutical industry to gather and organise clinical trial data, leading to quicker, more reliable trial outcomes. Our contribution to improving patients lives motivates us every day! Join our Bangalore team as a Helpdesk Supervisor to provide world class customer service over the phone in support of clinical trials deployed at hundreds of clinical sites worldwide. You will be part of a growing team in Bangalore, working directly with our clients and Clario colleagues across the globe - helping to bring new drugs to market, more quickly and more safely. See the impact you could have. What we offer: Competitive compensation + shift allowances Attractive benefits (security, flexibility, support and well-being) Engaging employee programs What youll be doing: The Helpdesk Supervisor coordinates and supervises the daily activities of Helpdesk staff, sets priorities for the team to ensure task completion; coordinates work activities with other supervisors. Responsible for establishing, maintaining and enhancing customer business through effective implementation and/or support of the company products and services. Manage the professional response to customer support requests in an accurate and timely manner, with input from the Manager, Customer Care. Determine appropriate action to ensure customer satisfaction while protecting the Customer Care divisions financial responsibility. Ensure that all customer contacts are fully documented into the call management system and the required databases. Manage the team to assist Customer Care Specialists/Representatives by identifying problem areas within product lines as they occur. Manage the collection and documentation of data necessary for problem areas to be researched appropriately. Responsible for assisting the QC analyst with any recommendations that are needed to be implemented within their team. Accurate, regular and timely reporting to the Manager, Customer Care. Define standard procedures according to the company standards. Manage, motivate and evaluate team to meet expected standards and procedures. Set, work on and reach Success Factor Goals related to future planning for the group as agreed upon with the Manager, Customer Care. Provide leadership through the coaching and supporting of team members Provide consistent, ongoing feedback to maintain and improve the team s performance. Responsible for one-on-one meetings to be held at a minimum of once a year that should take place prior to the year-end Success Factors process, including writing the Success Factor Year End Review for their team. Use communication skills as a tool to build excellent relationships with customers and colleagues and use cross-departmental communication to improve synergy effects, discuss and resolve issues. Act as a back-up performing Customer Care Representative/Specialist tasks as needed (anticipated at up to 30% of the time) Sets high standards of performance for oneself actively applies feedback received to daily work and strives to improve performance and regularly displays a positive attitude Take a broad view of the business by supporting initiatives in other departments as well as supporting new product lines. Provides reports upon request to the Manager, Customer Care as it pertains to the daily operating function of the Customer Care Department. Responsible for any special projects that may be assigned as needed by the Manager, Customer Care. The supervisor will provide updates to the status of the assignment, about differences in given deadlines, the measures taken and generally about all business-related aspects. What were looking for: Degree educated in electronics, information technology, engineering or similar Fluent in spoken and written English. Prior experience of managing a customer care or helpdesk team Experience providing support and service of technical or medical equipment Strong team work experience Demonstrates flexibility in daily work; available for off hours support during the course of the work week; required to be on-call during a rotating schedule for the weekends. Demonstration of self-composure in all customer relations, strong persuasion skills with customers Ability to work independently and effectively in given areas of responsibility Able to develop efficient problem solutions, business management techniques. Strong working knowledge of safety/security protocols, company policies, quality, ERP, CRM, office package and assigned products.

The Software Quality Engineer works (hands on) on the validation of study software as well as reviews and approves the CSV package according to the SOPs and Work Instructions. The SQE is also responsible for the overall test effort, quality, timelines for assigned projects, taking ownership of the project and clearing any roadblocks that arise in day to day. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Reviews (Manuals/Specification): Demonstrated ability to successfully complete tasks in this competency as requested. Review project relevant documents regarding testability, comprehensibility, plausibility, inconsistencies or quality gaps. Work with internal stakeholders to understand project requirements, providing experience and guidance regarding project risk and possible mitigation actions. Feedback of review results to internal department stuff and/or external teams. Test Case Design: Demonstrated ability to successfully complete tasks in this competency as requested. Definition of test case goals. Using test techniques for defining test cases. Definition of test cases with expected result (Integration test, functional test, performance test etc.). Definition of prerequisites for a test case. Traceability regarding requirements, test cases and test documents. Collaborate with developer or study implementation manager to understand the changes in new software versions and identify the appropriate set of functional and regression tests needed to verify that new features work as designed and do not cause any undesirable behavior. Test Execution: Demonstrated ability to perform the actions associated with this skill without assistance. Execution of predefined test cases on SUT. Creating meaningful test evidence (screenshots etc.). Create and use suitable test data. Test Result Analysis: Demonstrated ability to successfully complete tasks in this competency as requested. Compare and assess expected with actual test result. Identifying of deviations not stated in test documentation (violation of state-of-the-art and common sense expectations). Identify and report deviations. Test Reviews: Demonstrated ability to successfully complete tasks in this competency as requested. Check test cases and their execution for completeness/correctness. Check corresponding test documentation. Check test cases for conformity and completeness regarding applicable/covered requirements. Bug Handling: Demonstrated ability to perform the actions associated with this skill without assistance. Entering meaningful bugs into the bug tracking system, which are detailed and reproducible. Understand and apply bug life cycle. Finds root causes of bug / quality problems. Rating severity of bug. Prioritized bug retesting. Test Environment: Demonstrated ability to successfully complete tasks in this competency as requested. Setup and maintain/update configured test systems for test execution. This includes knowledge and use of applicable backend environments and dummy tools for testing purposes. Test Documentation : Demonstrated ability to successfully complete tasks in this competency as requested. Creation of all test documents needed for various test activities and applicable SOPs/procedures. Provide necessary documents to support audits (internal, external and by regulatory agencies). Follow all testing practices and procedures to meet regulatory compliance standards and Good Clinical Practices. Project Reporting (status, escalation) (working on one Project): Demonstrated ability to successfully complete tasks in this competency as requested. Report current status of assigned tasks/ projects to next reporting level (current status = done/todo/#bugs). Report current status of assigned tasks / projects to external parties. Attending status meetings and report current status for projects. Demonstrated ability to work under pressure and meet deadlines without supervision. Manage fair workload and volunteer for additional work, prioritize tasks, manage time well. Meets commitments, accepts accountability, sets personal standards, and stays focused under pressure. Provide accurate and timely input in the reporting system. Test Management (multiple projects): Demonstrated ability to successfully complete tasks in this competency as requested. Assign Engineer to projects/tasks (onsite and offshore). Plan test activities for upcoming testing projects (timeline and resources). Monitor current running projects regarding status, timelines, risks Recognizing and escalation project risks. Monitor testing tasks about efficiency and quality. Do follow-up on defects in defect tracking system and update priority and assignment as needed. Test Effort Estimations: Demonstrated ability to successfully complete tasks in this competency as requested. Estimate test effort for upcoming testing tasks/projects. Estimation of necessary prerequisite. Test Data Management: Demonstrated ability to successfully complete tasks in this competency as requested. Create and maintain necessary test data for positive/negative/border tests for different modalities (ECG, PFT, AM,etc). Working with Test Tools: Demonstrated ability to successfully complete tasks in this competency as requested. Work with established testing tools: Screenshot applications. Bug tracking system. Document Management System. Test Management System. Test Automation Suite. Continuously review department tools and provide guidance on tool improvements and/or efficiency. Project Reporting (status, escalation) (working on multiple Projects): Must have a basic understanding of: Report current status of assigned tasks / projects to next reporting level (current status = done/todo/#bugs). Engineer must be able to handle complete planning of study tasks for multiple projects (2+). Report current status of assigned tasks / projects to external parties. Attending status meetings and report current status for projects. Demonstrated ability to work under pressure and meet deadlines without supervision. Manage fair workload and volunteer for additional work, prioritize tasks, manage time well. Meets commitments, accepts accountability, sets personal standards, and stays focused under pressure. Provide accurate and timely input in the reporting system. Test Strategy/Concept Support: Must have a basic understanding of: Proactively deliver insight views of testing tasks/study. Participate in discussions on test approach for upcoming testing tasks (participate = suggest, confirm, discuss). Participate in test strategy document creation. Maintain a broad understanding of practices and developments in the Computing, Regulatory, Pharmaceutical and HealthCare industries. Attend UATs, customer calls and audits (internal, external and by regulatory agencies) as needed. Participate in Root Cause Analysis Sessions (CAPA). Test Process Improvement: Demonstrated ability to successfully complete tasks in this competency as requested. Provide proactively proposals to change, skip, add steps in the current applied test process to improve efficiency, effectiveness and quality. Identification of inefficient or error prone processes or process steps. Collaboration within/outside Department: Demonstrated ability to successfully complete tasks in this competency as requested. Deliver presentations, share information and ideas with others. Participate in cross-training activities (within and/or outside the department). Mentor, train and monitor new co-workers and their progress. Assist the department manager and contribute to departmental goals and efficiencies. Cross-collaboration with other departments. Demonstrates an ability to communicate and work with an offshore team when necessary. Demonstrates an ability to work under pressure and meet deadlines. Targets and achieves results, sets challenging goals, prioritizes tasks, overcomes obstacles, responds well to change. Practice self-development. manages a fair workload, volunteers for additional work, prioritizes tasks, and manages time well. Participates in cross-training activities, e.g. translations, formatting, package building/testing, etc. Communicates well both verbally and in writing, leverages multiple modes of communication, is responsive and courteous in interactions, provides an appropriate amount of information and detail. Is attentive to detail and accuracy, is committed to excellence, looks for improvement continuously, monitor quality levels. What were looking for BS, BA or equivalent in an Information Technology or related field required. 0-5 years software testing experience Intermediate understanding of Software Development Process ISTQB Foundation Level (optional) Ability to self-develop Intermediate experiences with Clario Software/Hardware Good English language skills (if applicable) Novice knowledge of Test Automation (if applicable) Novice knowledge of Agile Methodologies (if applicable)

We are seeking a highly motivated Validation Engineer to join our team at Clario. In this role, you will be responsible for validating and testing new Clario products and features, with a primary focus on data-driven platforms. You will work closely with product development, data engineering, and QA teams to ensure the quality, accuracy, and integrity of complex data pipelines and applications. The ideal candidate will have hands-on experience in ETL validation, big data platforms, SQL scripting, and Python programming , along with a strong understanding of testing methodologies in a regulated environment. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Experience in writing complex SQL queries and experience with any data visualization tool is preferable e.g., Tableau, Power BI. Good exposure of Software Testing methodologies, Implementation of Data Lakes, Data warehouse/ETL projects , Big Data projects in On-Premises & Cloud Environments. Experienced in SAS applications and Python Programming Ability to write SQL queries to conduct data validations and probe quality issues with data. Experience in Project Delivery Methodologies: SDLC, Iterative, Agile, Scrum, Kanban Experience in ALM Tools like JIRA, TFS (Azure Devops) & Confluence. Knowledge on data quality fundamentals and data governance concepts. Hands-on experience with all levels of testing includes Smoke Testing, Integration Testing, System Testing and Regression Testing. Knowledge of PL-SQL, PySpark & SQL, on framing and tuning the Queries so that it covers all the data scenarios. Accountable for high quality and on time delivery for task assigned. Good knowledge in MS Office Tools Tracking all software versions, features, bugs and validation efforts for all software created and/or modified by the Development teams. Developing and utilizing test data sets. Creating and executing manual test scrips which includes testing software applications for quality and functionality using defined validation protocol and testing techniques. Creating associated validation documentation using defined documentation methods. Working with application developers in resolving issues and retesting applications. Good verbal and written communication. Actively participates in the testing of new Clario products by: Developing test cases and study data Conducting testing for general testing Conducting testing for Clinical Services development tools Reporting testing and review anomalies, as appropriate, to the department head Actively participates in post-production product release testing by: Developing test cases Conducting regression and bug fix testing for Clinical Services. Report testing and review anomalies. Exploring new opportunities to add value to organization and departmental processes. Attending and participating in applicable company-sponsored training Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) Establishing and enforcing departmental standards Exploring new opportunities to add value to organization and departmental processes. Helping others to accomplish results. Performing other duties as assigned Attending and participating in applicable company sponsored training. Attending educational workshops and reviewing professional publications Benchmarking state-of-the-art practices Participating in professional societies Keeping informed of changes in the regulatory environment and/or regulatory requirements. What Were looking for Bachelor s degree required in computer sciences, or equivalent and relevant work experience in a software Testing environment. Around 1 to 6 years of experience in Software Quality Testing. Prior testing experience with pharmaceutical related software, preferred. In-depth understanding of software quality assurance, preferably in a Clinical Data environment. Ability to write SQL queries to conduct data validations and probe quality issues with data. Experience in Project Delivery Methodologies: SDLC, Iterative, Agile, Scrum, Kanban Knowledge and understanding of the Software Development, Life Cycle (SDLC) testing methodology and document management. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) Experience in writing test cases based on product requirements. Experience working closely with development and business teams to communicate problem impacts and to understand business requirements. Shows creativity and initiative to improve product test coverage and effectiveness (preferred) Experience with web based SAAS platforms (preferred) Knowledge of cloud-based testing preferred. Having knowledge in programming like Python (preferred) Demonstrates required verbal and written communication skills including ability to communicate remotely. Strong interpersonal and communication skills, both verbal and written Goal oriented Ability to make sound judgments. Superior problem-solving skills Ability to manage multiple tasks effectively & efficiently.

Primary Responsibilities Provides data to clients (internal and external) in functional format by: Creating and executing SAS edit check programs Validating edit check programs using standard validation practices and processes Creating, validating and executing SAS programs and macros Utilizing SAS programming skills to provide ad-hoc reports (external and internal) Assist in developing programming specifications Assist in creating program specific validation plans Identifying and implementing solutions for complex reporting needs Ensures client data accuracy and integrity by: Creating and/or reviewing data editing and export specifications Working directly with clinical data manager, and where needed with clinical project manager and other team members to ensure specifications are clear and accurate. Has a clear understanding of the contextual requirements for reporting outputs; and provides feedback Programming data cleaning/consistency checking programs to support internal applications for all therapeutic areas Programming and testing data export programs in accordance with specific client needs Documenting all programming and validation efforts in accordance with Good Clinical Practices Monitoring data integrity throughout a given study Utilizing SDTM guidelines to create transfer datasets Participating in project meetings (internal and external) Develops and maintains clinical programming standard operating procedures by: Participating in the development of data editing conventions, specification documents and Clinical Data Management (CDM) processes Contributing to, designing and maintaining a library of reusable code Leading and managing enhancements to current CDM systems and providing inputs in the implementation of new systems. Ensures project timelines are maintained by: Working independently and efficiently with minimal input required from the manager. Reviewing timelines; and projecting estimates and target dates in conjunction with direct supervisor and project team Adhering to target dates for project timelines Communicating any changes in target date to appropriate personnel including Project Manager Keeping department head informed of progress as well as potential impediments Maintains Quality Service and Departmental Standards by: Adhering to established processes and standards Reading, understanding and adhering to organizational Standard Operating Procedures (SOP) Assisting in establishing and enforcing departmental standards Maintain and review clinical programming SOPs Participating in the modification of company SOPs Secondary Responsibilities Contributes to team effort by: Working with internal staff to resolve issues Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned Maintains Technical and Industry Knowledge by: Attending and participating in applicable company-sponsored training Qualifications: Education: Bachelor s or Master s degree in computer science, life sciences or related field required SAS Certified Professional considered a plus Experience: 3 years SAS programming experience in pharmaceutical related industry required (1 year with Master s degree) Experience working with CDISC, SQL, and Relational Databases preferred Demonstrated programming skills required Working knowledge and solid understanding of database organization and how to extract data in order to generate listings and reports Proven ability in analyzing data Understanding of medical and/or clinical trial terminology is desirable Proven ability in problem solving Additional skill set: Ability to work in group setting and independently; ability to adjust to changing priorities Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation and organizational skills Ability to project and maintain a professional and positive attitude Working conditions: Travel: 0-5% Lifting: 0-10lbs Other: Computer work for long periods of time EEO Statement Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic

BASIC PURPOSE:Manage the whole training translation process including vendor communications, Purchase Order & Billing administration as well as stakeholder management, while also supporting additional business administrative tasks across the Client Education team. ESSENTIAL DUTIES AND RESPONSIBILITIES: Manage the purchase and invoicing process for any costs incurred during the development of client training or operational management of the Client Education team. This includes: Identify budget required for cost Initiate purchase order Review and approve invoices Update study budget files accordingly Monitor and report on expenses related to consultant use to conduct live training. Prepare and deliver any requested reports and KPIs. Oversee the invoicing for any client training deliverables. Manage the software and device distribution and costs for the Client Education team. Maintain and support any automation or databases used by the Client Education team. Coordinate the translation of training material, created by the client education content developer. This includes: Submit translation requests through the vendor portal. Inform internal stakeholders or requestors of expected translation timelines. Manage and coordinate the translation vendors activities, addressing incoming questions and requests, and escalating to the appropriate internal stakeholders as needed. Proactively identify and communicate any potential risks. Initiate the deployment or distribution of translated materials. Support and participate in testing the deployment of translated content. Update internal databases with translation project details and status. Create purchase orders and manage invoice processing for translation services. OTHER DUTIES AND RESPONSIBILITIES: Provide support and training for new team members. Educate other functional areas and internal/external stakeholders on business admin processes. Evaluate internal process for continuous improvement and/or efficiency improvement. Participate in cross-functional teams to drive improvement initiatives. Create, review and update standard work instructions (SWI, SOP) The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. The Company reserves the right to amend or change this job description to meet the needs of the Company. This job description and any attachments do not constitute or represent a contract. QUALIFICATIONS AND SKILLS NEEDED: Education : Associates degree or equivalent in business administration. Experience : 3-4 years of experience in similar job position. Strong organization and time-management skills, and attention to detail. Excellent verbal and written communication and interpersonal skills. Independent working Working conditions: Other: Computer work for long periods of time The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications. This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs. EEO Statement .

Responsible for assisting Project Management personnel with various tasks throughout the study lifecycle. ESSENTIAL DUTIES AND RESPONSIBILITIES: Assist with the Planning and Setup, Monitoring, and Closeout Phases of study management which may include: Database setup. Study documentation development. Equipment distribution/tracking. Report creation/distribution. Archival of study documentation. Coordinate Project Assurance meetings and assist with compiling meeting minutes and action items. Support financial components of study management including: Assistance with documentation/database updates due to scope changes. Follow-up related to invoice reconciliations. Preparation of reports in support of study forecasting activities. Facilitate issue management by documenting and tracking progress to ensure timely resolution to customer escalations. OTHER DUTIES AND RESPONSIBILITIES: Ensure compliance with timely training completion/documentation. Respond to customer inquiries and participate in customer calls/meeting upon Project Manager s request. Take the lead in managing various aspects of a project as requested. Other related projects and tasks as assigned. QUALIFICATIONS AND SKILLS NEEDED: Education : Bachelor Degree preferred. Experience : At least 1-3+ years of experience in pharmaceutical field (or related industry experience). Knowledge of the drug development process. Good organizational, interpersonal, time management, and prioritization skills Excellent verbal and written communication skills, including ability to communicate effectively in English. Detail oriented and responsive to inquiries and requests. Working knowledge of Microsoft Office products.