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Typical Daily Work schedule (start/end times) - 830-5 (some flexibility in start/end times as long as full day is worked)
Weekend work not required, but might be needed on occasion (would coord hrs so as not to go into Overtime)
100% onsite for first few months, Mgr might consider some offsite later on.
CORE JOB FUNCTIONS:
• 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 Client standards and processes
• Serve as the DM representative on clinical project teams that are developing NDAs
• IMPORTANT: Manager is looking for extra strong candidate that pick-up and learn quickly. Not looking for entry level. Candidate must be open-minded to new processes and new direction from what they may be used to.
• 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
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