Lead Clinical Data Manager
Location: Summit, NJ (100% onsite work)
Duration: One year from start date (12 months)
- Typical Daily Work schedule (start/end times) = 40 hr/week, 8am-4pm (with some flexibility in start/end times as long core hours of 9am through 3pm are covered)
- Weekend/OT work may be needed, so candidates should be open to it.
About the Company:
A Global Pharma company headquartered on the East Coast are seeking a Clinical Data Manager with experience in and knowledge of external data management and the full CDM process from study start-up to database lock. The CDM will work with ongoing clinical studies within varied therapeutic areas.
- Data Management Lead experience is essential. As a senior level contractor, responsibilities will include, but are not limited to:
- Overseeing the management of clinical trial databases from study start up to study closure at CRO (or when required, support other DMs) by performing the following activities:
- 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.
- Lead Case Report Form Design according to the protocol with all Study Team members using established standards
- Author or review CRF completion guidelines
- 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.
- Develop and test edit specifications which may include the development of test scripts used for UAT as well as perform/coordinate UAT testing
- Ensure coding has been performed and reviewed by Medical Coder,
- Perform external data reconciliation, provide data management related metrics, provide specific data listings as required by the medical group and review when necessary
- Make data, including interim data, available to company personnel and to regulatory agencies when required
- Trouble-shoot database issues with DBA until resolution is obtained
- Perform database lock and freeze activities
- Prepare and present data collection requirements at Investigator Meeting
- Participate in CRO selection
- Review SOWs for data management activities and costs in contracts
- Participate in regular team meetings and provide input when appropriate
- Other Activities may include
- Interact with physicians, scientists, monitors, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
- Assist in database upgrades/migrations including performing User Acceptance Tests
- 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 5 years of experience as a LEAD data manager in a pharmaceutical/CRO setting
- Experienced in understanding Sponsor responsibilities of oversight of a CRO.
- Immunology, Inflammatory and Clinical Pharmacology is highly desirable,
- Proficient knowledge of Medidata RAVE, Experience with RaveX is a plus
- Knowledge of of JReview is a plus.
- Basic knowledge of budget forecasting
- Proficiency in regulatory guidelines, agencies, GCP
- Advanced knowledge of clinical trial process and data management process
- Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
Why work here?
- This is an excellent opportunity to join a fast-paced, hardworking team at a Biotech & Pharma leader on the Fortune 500 list. With over a 90% CEO approval rate and an 80% recommendation rate on Glassdoor, this company is the ideal environment to build your career and excel as a Clinical Data Manager.
Sthree US is acting as an Employment Business in relation to this vacancy.