Senior Clinical Data Manager
Jersey City, NJ
We are currently searching for a skilled professional to join a well-known client’s team as Senior Clinical Data Manager in Jersey City, New Jersey. The Senior Clinical Data Manager is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan, coordination of Centralized Data review activities, and is accountable for data integrity, quality, and consistency. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Responsible for the management and maintenance of clinical data and interfacing with clinical teams
- Provides leadership and content expertise for Clinical Data Management activities from startup through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities
- Member of the Protocol Review Team, CRF Review Team, Medical Safety Monitoring Plan Reviewer, member of the Clinical Study Report Review Team, and may perform peer review of Clinical Data Management deliverables as a Peer Data Management Lead
- Key contact for Statistical Sciences and Programming (SSP), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety &Epidemiology (GPSE), Clinical Development, and NonTranslational Sciences (NTS).
- May be responsible for participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.)
- Involvement in assessment or reassessment of vendor capabilities
- Delivering training to Clinical Data Management and other functions and departments
- Demonstrated ability in Clinical Research, Computer Science, Project Management or related field
- Strong knowledge of research and development, clinical trials execution, and understanding of regulatory requirements and guidelines (e.g. ICH, GCP, safety reporting)
- Strong knowledge of computerized systems in clinical trials
- Strong knowledge of global standards related to clinical data management activities
- Bachelor’s Degree
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.