Premier Research is looking for a Application Services Engineer II to join our IT & Corporate Administration team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. Location: India Shift timing: 12 Pm to 9 Pm IST What You Will Be Doing The Application Services Engineer will assist with providing technical support and technical administration of Premier's corporate and clinical applications including: Resolving end user issues in specialized systems through a ticketing system while meeting SLAs put in place by the Technology leadership team and the business Assist with system upgrades and patches as needed with properly documented test cases Assist with integration requirements, building, testing and documentation to provide required system data for consumption by other applications Ability to build and run SQL scripts to identify data problems and help provide recommended solutions Ability to design and build xml-based Web service integrations (SOAP and REST) to integrate enterprise systems Development and maintenance of documentation for business processes supported by the systems and integration points/requirements Creation of knowledge base articles that can be added to the help section the corporate IT Service Management system Setup of security models for supported systems as well as assists as needed with audit requests Assist senior team members with projects while keeping project team members, stakeholders, vendors, and senior IT management informed of issues and overall status What We Are Searching For Bachelor's degree and 1-2 years IT experience supporting enterprise level applications, preferably in a life sciences-based company, or an equivalent experience of 2-4 years with demonstrated experience in corporate application administration. Experience of technical support/administration of corporate applications that utilize an application frontend and database backend. Finance, Human Resources, Clinical, Corporate Reporting systems experience preferred. Core systems include – Workday, Salesforce, OneStream, Freshworks, Argus, Cornerstone, Ideagen - iQM, Smartsheet, other corporate and clinical applications as required. Experience supporting corporate application modules within a team environment Understanding of Web services and integration mechanisms, XML and/or XSLT experience is desired Oracle and SQL Server database administration is a plus Fluent verbal and written English Excellent team player; collaborative and consensus builder Ability to multitask and work effectively in a fast-paced environment with changing priorities Strong verbal and written communication and negotiation skills Excellent organizational and time-management skills, able to prioritize work to meet deadlines Strong desire to learn new skills and expand technical experience Accountable, dependable, and strong commitment Customer service focused approach to work both internally and externally Maintains a positive, results orientated approach Ability to work both independently and in a team environment Show more Show less
Premier Research is looking for a Data Management Reporting Programmer (SQL Developer) - Fixed Term Contract - India to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. What You Will Be Doing Works with cross-functional study team members in a programming capacity to create reporting solutions that support the quality and timely delivery of data management reports and visualizations required per standard and study specific data review plans Creates, enhances, and decommissions data management reports in accordance with applicable standard operating procedures Ensures timelines and milestones are met in collaboration with cross functional teams Creates any needed documentation for reports and ensures proper filing Works across the portfolio to increase automated reporting (e.g. - JReview, Spotfire) and review in order to streamline effort on data intensive studies Enhances available reporting tools or creates new ones to support the review of clinical trial data and trial status information for cross-functional use Provides input on data management reporting standards as required What We Are Searching For Bachelor’s degree, or international equivalent from an accredited institution, preferably in a programming, technical, clinical, or health-related field, or equivalent combination of education, training and experience 3 to 5 years of practical experience using commercial clinical data management systems (eg – Oracle RDC / Inform, Medidata Rave, Datalabs, etc) or data visualization reporting tools (e.g. Spotfire, jReview). Alternatively, must have proven experience in all primary job functions Practical experience with SQL or similar programming language required Demonstrates excellent English verbal and written communication skills Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc) Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities Show more Show less
Premier Research is looking for a Principal Biostatistical Programmer to join our Biostatistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. This role will be specifically working in our end-to-end team therefore SDTM, ADaM and TLF experience is required. What You'll Be Doing Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells Performs quality control (source code review, double-programming and log review) of SAS programs Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications Prepares specifications for CDISC and other analysis data sets Assists Data Management with SAS programming needs Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team Develops and validates general SAS macros What We Are Searching For BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role 6-8 years of experience in SAS programming within the area of clinical trials. Prior experience using computerized information systems preferred. Knowledge of ICH and local regulatory authority drug research and development regulations preferred. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms. Show more Show less
Premier Research is looking for a Associate Database Developer (Fixed Term Contract) - India to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. Responsible for the configuration of project databases, tools, and utilities using Clinical Data Management Systems (CDMS) and underlying database platforms for the purposes of capturing accurate clinical trial data. What You'll Be Doing Creates electronic Case Report Forms (eCRFs) according to finalized protocols and study design specifications for Electronic Data Capture (EDC) studies Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies Communicate with data management and study management teams throughout all study start up activities to ensure team needs are understood and met. Designs, builds, and tests clinical databases according to Standard Operating Procedures (SOPs) Programs field derivations, edit checks, consistency checks, validations, procedures and rules. Writes data extraction programs Develops of study reporting environment which includes CRF and non-CRF (loaded) data in addition to transforming collected data to required reporting format. Ensures database documentation is maintained for the Trial Master File (TMF) Works in collaboration with the sponsor and study team to define all technical elements of the Data Management Plan What We Are Searching For Bachelor's degree, or international equivalent from an accredited institution, preferably in a technical field, or equivalent combination of education, training and experience 0 to 3 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions. 1 to 2 years of SQL programming experience preferred Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Demonstrates excellent English verbal and written communication skills Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities Familiarity with drug development and clinical trial processes preferred
Premier Research is looking for a Associate Data Manager - FS (4 month fixed-term contract) to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. What We Are Searching For: Assists in preparing clean databases by performing a review of clinical trial data through the CDMS or external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan Provide input to and review of Data Management Plans in support of clinical study deliverables Generates queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates, and client representatives) to resolve problematic data identified during every aspect of the data management process Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies the database accordingly Supports the development of CRFs and edit check specifications per protocol and participates in user acceptance testing of CRFs and associated edit check specifications as required Assists in the user acceptance testing for study-specific data listings ensuring data output adheres with requirements Prepares and maintains documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required What We Are Searching For: Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience 3 to 5 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions. Demonstrates excellent English verbal and written communication skills Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc) Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
Premier Research is looking for a Data Coordinator - DM to join our Clinical Data Sciences team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. What You'll Be Doing Assists in testing of databases (DBs) and maintenance of study data, including the processing of discrepancies and queries. Reviews Case Report Forms (CRFs), data listings, and DBs to ensure that all captured data follow the rules outlined by the protocol, CRF Completion Guidelines (CCGs) and departmental plans. Collaborates cross-functionally with colleagues to ensure the integrity of clinical databases. Prepares documentation, such as CCGs, Data Management Plan (DMP), Data Report Assists in developing standard test data for testing screens and listings and provides feedback on the results of the testing Performs user acceptance testing on studies, including testing of edit checks, etc. Assists in maintaining DBs and supports DB updates Performs data entry Generates reports for data review Reviews CRFs, data listings, and DBs to ensure all data captured follow protocol, CCGs, DMP, etc. Generates queries to appropriate internal or external personnel (e.g., investigational sites, Clinical Research Associates and client representatives) to resolve problematic data identified during various aspects of the data management (DM) process Reviews responses to queries and resolves discrepancies Performs external data and/or serious adverse event reconciliation Acts as a Lead Data Coordinator and/or Safety Reviewer on multiple studies Performs document submission to Trial Master File (TMF) Supports TMF Quality Control (QC) activities Performs database QC activities Performs QC of study reports, CRF archive files Supports the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, project status What We Are Looking For Bachelor’s Degree or above (preferably in a Life Science) Typically requires 2 -4 years of DM mastery or related clinical research industry experience Knowledge of at least one Clinical Data Management System (CDMS) (e.g. Medidata Rave, Calyx EDC, etc.)
Premier Research is looking for a Director, Biostatistical Programming to join our Biostatistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. What You'll Be Doing The Director, Biostatistical Programming serves as core team member and leader for larger projects. This position is responsible for Biostatistical Programming operations, directing project assignments, and the overall activities of project team personnel. The Director also reviews departmental deliverables for accuracy, completeness, and compliance with project specifications to ensure quality deliverables to Sponsors. The Director is responsible for both management and technical aspects of development projects. As a technical expert, this individual provides strategic guidance to development projects. When functioning in a supervisory role, the Director provides coaching guidance to more junior staff and line management to the team, while overseeing the technical evolution of the departmental work product. Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop and maintain the team structure Provides support for the maintenance and management of the biostatistics macro library Prepares specifications for CDISC and other analysis data sets Performs QC (source code review, double-programming and log review) of SAS programs Participates in and contributes to the training and development of new Biostatistical Programmers Lead efforts in the development, maintenance and adherence to departmental SOPs and guidelines Keeps up on CDISC and other industry standards and ensures dept is kept up to date Integrates operational practices within the department across all offices/regions Develops SAS programs to generate tables and listings without shells Develops SAS programs to generate listings, tables and graphs as outlined by TLF shells Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications Develops listing shells for SAP Develops and validates standard macros and template programs using SAS and other software tools Develops and validates general SAS macros Develops and implements non-SAS software Creates define packages for CDISC datasets Contributes to the tracking of project revenue and backlog Contributes to the tracking of hours worked on projects and forecasts hours to complete Contributes to the definition of standards and harmonized procedures across offices/regions Contributes to efforts in Biostatistics project costing estimates and change order process Capability and willingness to coach and mentor others Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team What We Are Searching For BS or equivalent from accredited college or university, in statistics, IT, mathematics or equivalent experience with programming in a scientific field. Equivalent combination of education, training and experience will be considered. 15+ years’ experience in SAS programming within the area of clinical trials. 7+ years’ experience as supervisor/manager Demonstrated excellent knowledge of data processing, database design and organization in clinical data environment. Demonstrated excellent knowledge of basic clinical trial design and analysis principles. Excellent working knowledge of CDISC standards and application of these standards to projects. Excellent working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics. Strong computer skills, with evidence of advanced SAS programming skills. Ability to support Biostatisticians with advanced statistics with little or no supervision on standalone projects. Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques. Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms. Detail oriented, well organized. Excellent English Communication skills (verbal, written & interpersonal).
Premier Research is looking for a Associate Technical Project Manager (6 month Fixed Term Contract) to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. What You Will Be Doing Assists in the management technical projects and collaborates with cross-functional teams to ensure milestone achievement and overall project delivery Maintains project timelines for multiple concurrent deliverables using Microsoft Project Online or other project management software Develops and monitors project progress and drives the identification and management of risks, collaborating with line manager and senior team members to develop mitigation strategies or contingency plans when triggers are detected Drives the quality of project deliverables through addressing the quality issues with the appropriate team members Ensures key stakeholders are regularly informed of key project metrics Responsible for high touch customer service and acting as the single point of contact for the project team Facilitates project team meetings, both internal and external, and other meetings as applicable. What We Are Searching For Bachelor’s degree, or international equivalent from an accredited institution, preferably in a technical field, or equivalent combination of education, training and experience 3 years of practical experience with project management of technical projects or ensuring adherence to clinical trial timelines. Basic level SQL knowledge is a must Clinical or related industry experience required Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Ability to work well with cross-functional teams (technical and non-technical) Strong analytical and organizational skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)
Premier Research is looking for a Associate Data Manager - Fixed Term Contract - India to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech. Join us and build your future here. What You&aposll Be Doing Assist in preparing clean databases by performing a review of clinical trial data to ensure all captured data follows the rules outlined by the protocol and Data Management Plan Provide input to and review of Data Management Plans in support of clinical study deliverables Review responses to queries for appropriateness, resolve any discrepancies, and modify the database accordingly Support data entry testing to ensure data can be input into the database as intended by the database design. Support query testing (edit checks) to determine data entered to a clinical database outside of expected values or ranges are prompted for further review. Assist in the user acceptance testing for study-specific data listings ensuring data output adheres with requirements Prepare and maintain documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required What We Are Searching For Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience Preferred 1 to 2 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions. Demonstrates excellent English verbal and written communication skills Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc) Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities Show more Show less
Premier Research is looking for a Data Management Reporting Programmer (6 month fixed-term contract) to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What You Will Be Doing Works with cross-functional study team members in a programming capacity to create reporting solutions that support the quality and timely delivery of data management reports and visualizations required per standard and study specific data review plans Creates, enhances, and decommissions data management reports in accordance with applicable standard operating procedures Ensures timelines and milestones are met in collaboration with cross functional teams Creates any needed documentation for reports and ensures proper filing Works across the portfolio to increase automated reporting (e.g. - JReview, Spotfire) and review in order to streamline effort on data intensive studies Enhances available reporting tools or creates new ones to support the review of clinical trial data and trial status information for cross-functional use What We Are Searching For Bachelor’s degree, or international equivalent from an accredited institution, preferably in a programming, technical, clinical, or health-related field, or equivalent combination of education, training and experience 3 to 5 years of practical experience using commercial clinical data management systems (eg – Oracle RDC / Inform, Medidata Rave, Datalabs, etc) or data visualization reporting tools (e.g. Spotfire, jReview). Alternatively, must have proven experience in all primary job functions Practical experience with SQL or similar programming language required Demonstrates excellent English verbal and written communication skills Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc) Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
Premier Research is looking for a Associate Technical Project Manager (6 month Fixed Term Contract) to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What You Will Be Doing Assists in the management technical projects and collaborates with cross-functional teams to ensure milestone achievement and overall project delivery Maintains project timelines for multiple concurrent deliverables using Microsoft Project Online or other project management software Develops and monitors project progress and drives the identification and management of risks, collaborating with line manager and senior team members to develop mitigation strategies or contingency plans when triggers are detected Drives the quality of project deliverables through addressing the quality issues with the appropriate team members Ensures key stakeholders are regularly informed of key project metrics Responsible for high touch customer service and acting as the single point of contact for the project team Facilitates project team meetings, both internal and external, and other meetings as applicable. What We Are Searching For Bachelor’s degree, or international equivalent from an accredited institution, preferably in a technical field, or equivalent combination of education, training and experience 3 years of practical experience with project management of technical projects or ensuring adherence to clinical trial timelines. Basic level SQL knowledge is a must Clinical or related industry experience required Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Ability to work well with cross-functional teams (technical and non-technical) Strong analytical and organizational skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)
Premier Research is seeking a Data Coordinator - DM to join the Clinical Data Sciences team. In this role, you will play a crucial part in assisting biotech, medtech, and specialty pharma companies in translating life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. Your contributions will directly impact saving and improving lives, as we recognize our team members as our most valuable asset in achieving success. As part of our team, you will be supported in your growth and provided with the necessary skills and opportunities to excel at work while maintaining the flexibility and balance needed in your life. Your ideas will shape the way we operate, and your voice will be valued within our organization. Together, we are dedicated to delivering the medical innovation that patients are eagerly awaiting, making a difference in the field of biotech. Your responsibilities will include assisting in testing and maintaining databases, reviewing Case Report Forms (CRFs), data listings, and databases to ensure compliance with protocol guidelines, collaborating with colleagues to ensure database integrity, preparing documentation such as Data Management Plans (DMP) and Data Reports, developing standard test data, performing user acceptance testing, data entry, generating reports for data review, resolving data discrepancies, and supporting various data management processes. To be successful in this role, you should hold a Bachelor's Degree or above, preferably in a Life Science field, and have 2-4 years of experience in Data Management or related clinical research industry. Additionally, knowledge of at least one Clinical Data Management System (CDMS) such as Medidata Rave or Calyx EDC would be beneficial. If you are looking to contribute to impactful projects, grow in your career, and be part of a team dedicated to making a difference in the biotech industry, we invite you to join us at Premier Research and build your future with us.,
Premier Research is seeking an Associate Director, TMF Process, Systems, and Training to join the Pharmacovigilance and Records Management team. In this role, you will play a pivotal part in assisting biotech, medtech, and specialty pharma companies in translating groundbreaking ideas and scientific advancements into new treatments. Your work will directly impact saving and enhancing lives, highlighting the invaluable contribution of our team members towards achieving success. As an essential member of our team, you will be instrumental in driving the improvement of TMF processes, systems, and training within Global Records Management (GRM). Collaborating with Departmental Leadership, you will oversee the management of GRM staff and take charge of TMF processes and systems utilized in the management of Trial Master Files (TMFs) on a global scale. Your strategic leadership will be crucial in addressing complex issues, optimizing TMF management services, and ensuring compliance with regulations and guidelines. Additionally, you will be responsible for cultivating a high-performing team, overseeing training activities, and leading efforts to address TMF-related issues. To excel in this role, you should possess a minimum of an undergraduate degree in records and information management, clinical, science, or a related field. You must have extensive experience in TMF management processes, systems, and training within the CRO, pharmaceutical, or medical device industry. Proficiency in systems training with platforms like Trial Interactive, Veeva Vault, and/or Wingspan is essential. Strong knowledge of ICH-GCP guidelines and global regulations related to TMF management is required. Excellent interpersonal and communication skills are vital, along with the ability to adapt to changing requirements in a fast-paced environment. You should also demonstrate leadership skills, organizational capabilities, and a customer-centric approach in your work. In summary, as the Associate Director, TMF Process, Systems, and Training at Premier Research, you will play a pivotal role in ensuring the efficient and compliant management of TMFs, contributing to the delivery of high-quality medical innovations. If you are seeking a challenging yet rewarding opportunity to make a meaningful impact in the field of biotech, we invite you to join us and build your future at Premier Research.,
Premier Research is seeking an Associate Database Developer for an 8-month contract in India to join the Functional Services Provider (FSP) team. In this role, you will contribute to the transformation of life-changing ideas from biotech, medtech, and specialty pharma companies into new medicines, devices, and diagnostics. Your work will play a crucial role in saving and enhancing lives, and we value our team members as our most important asset for achieving success. We are committed to supporting your growth, providing you with the necessary skills and opportunities to thrive at work while maintaining the flexibility and balance that your life demands. Your input shapes our work culture, and your voice is highly valued within our team. Together, we are dedicated to advancing medical innovation that patients urgently need in the biotech field. Join us and build your future here. As an Associate Database Developer, your responsibilities will include configuring project databases, tools, and utilities using Clinical Data Management Systems (CDMS) and database platforms to ensure accurate clinical trial data capture. Your key tasks will involve creating electronic Case Report Forms (eCRFs) based on finalized protocols and study design specifications for Electronic Data Capture (EDC) studies. Additionally, you will develop data entry screens in alignment with approved annotated Case Report Forms (CRF) for paper studies. Effective communication with data management and study management teams throughout all study start-up activities is essential to ensure that team requirements are clearly understood and met. You will design, build, and test clinical databases following Standard Operating Procedures (SOPs), program field derivations, edit checks, consistency checks, validations, procedures, and rules. Furthermore, your role will involve writing data extraction programs, developing a study reporting environment that includes CRF and non-CRF (loaded) data, and transforming collected data into the required reporting format. It is crucial to maintain database documentation for the Trial Master File (TMF) and collaborate with the sponsor and study team to define all technical elements of the Data Management Plan. The ideal candidate for this position will have a Bachelor's degree or international equivalent, preferably in a technical field, or an equivalent combination of education, training, and experience. Practical experience using commercial clinical data management systems and/or EDC products such as Oracle RDC/Inform, Medidata Rave, or DataLabs is preferred. SQL programming experience, positive customer interaction skills, excellent English verbal and written communication abilities, strong analytical and organizational skills, and the capacity to work independently and manage multiple projects in a fast-paced environment are desirable qualities for this role. Familiarity with drug development and clinical trial processes would be advantageous.,