US-MA, Sr. Lead Data Manager--Large Global Pharma CDM-MZ
Tech Data Service Company is a staffing firm for clinical data manager professionals. Our clients are most of the major pharmaceutical companies and many other CROs, pharmaceutical and Biotechnology companies. We can often submit your resume to multiple companies and for multiple positions with multiple clients. Tech Data is a leading provider for temporary and permanent positions in the pharmaceutical industry. Tech Data offers the most competitive pay rate and benefits in clinical research consulting services.
If you are interested in this position, please contact Lu Cheng at [click here]
1.Job Title: Sr. Lead Data Manager
Contract position – one year contractor and have a high chance to extend
Location: Summit, NJ
• Oversee the management of clinical trial databases from study start up to study closure.
(A) Be able to review and understand protocol synopsis and attend if required any protocol review meetings and act as subject matter expert for proper data capture based on protocol requirements.
(B) Lead Case Report Form Design according to the protocol with all Study Team members using establed standards
(C) Author and or review CRF completion guidelines
(D) Develop or lead in the review of a Data Management Plan (DMP), when applicable, that outlines database design and testing, CRF flow, data queries, manual checks, coding, SAE reconciliation, third party vendor reconciliations, specification of data listings needed to facilitate data cleaning in accordance to a Data Review Plan, data lock and archiving, etc.
(E) Develop and test edit specifications which may include the development of test scripts used for UAT as well as perform/coordinate UAT testing
(F) When applicable ensure coding has been performed and reviewed by Medical Coder, Perform external data reconciliation, Provision of data management related metrics, provision of specific data listings as required by the medical group and review when necessary
(G) Make data, including interim data, available to company personnel and to regulatory agencies when required
(H) Trouble-shoot database issues with DBA until resolution is obtained
(I) Perform database lock and freeze activities
(J) If required prepare and present data collection requirements at Investigator Meeting
(K) Be experienced in the management and oversight of CROs and consultants:
(L) Participate in CRO selection if required
(M) Be able to Review SOWs for data management activities and costs in contracts
(N) Interact with CROs in the design and development of databases that are compatible with company needs, monitor progress of data management activities in CROs
(O) Participate in regular team meetings and provide input when appropriate
• Assist in database upgrades/migrations including performing User Acceptance Tests
• Train Data Managers on Celgene standards and processes
• Serve as the DM representative on clinical project teams that are developing NDAs
• BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience as a LEAD data manager in a pharmaceutical/CRO setting
• Must be a Senior Level Person and familiar and experienced in all aspects of Data Management Responsibilities.
• Must be familiar with all phases of clinical trials (Phase 1 – Phase 4).
• Must have experience on Phase 1 studies as a Sr Level person assigned to more complex studies
• Oncology experience
• Proficient in writing function SOPs/Working Practices
• Ability to interact with physicians, scientists, monitors, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
• Experienced in understanding Sponsor responsibilities of oversight of a CRO.
• Proficient knowledge of EDC preferably Medidata RAVE. Knowledge of JReview is a plus.
• Basic knowledge of budget forecasting
• Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
• Proficiency in regulatory guidelines, agencies, GCP
• Advanced knowledge of clinical trial process and data management process
2. Global Leading Pharmaceutical Company
Job Title: Lead Clinical Data Manager
Contract position – 6 months contractor and renewable
The Clinical Data Manager will have a demonstrated ability to oversee the data management activities across a single clinical program or group of related studies. Provides Data Management leadership and expertise to project and study teams. Will have an good knowledge of the end to end clinical research and data management processes, as well as global regulatory and industry rules and guidances (i.e. ICH, GCP) to support drug development processes and global project submissions through to approval.
Responsible for managing data management components of project and study budgets and vendor performance. May mentors team members and more junior staff and may direct activities of contract Data Manager staff .
Job Function and Description Delivering Excellence: Takes leadership role in project implementation As a member of the clinical study or project team, ensures oversight of the Data Management CRO ; provides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the CRO Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation, testing and implementation of SAS data deliverables according to internal and regulatory standards Works with team members via matrix relationships (internally or at CROs) by directing work, resolving problems and/or providing guidance
Global Leading Pharmaceutical Company
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