Senior Clinical Data Manager
San Francisco, CA
We are currently searching for a skilled professional to join a well-known client’s team as Senior Clinical Data Manage. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Senior Clinical Data Manager is responsible for overseeing Data Management operational activities, ensuring compliance with the corporate timeline and scope of work outsourced to the Data Management service provider (SP) and coordinating activities from other external vendors that may also provide study data
- This position reports to the Head of Data Management and may report to Associate Director, Data Management or Senior Manager, Data Management.
- Oversee and manage Data Management related activities outsourced to Data Management Vendors as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget
- Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
- Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications
- Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, and CRF (eCRF) completion / monitoring conventions
- Develop and test data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
- Participate with the Study Operations Teams (SOTs) for all study activities, and lead all Data Management functional activities using established templates/processes as applicable
- Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data
- Minimum of 5 years of Data management experience in the pharmaceutical, biotech and/or CRO industries, with experience in managing data from Phase III clinical trials
- Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). CCDM Certification a plus
- Knowledge and experience with various clinical databases (e.g., Medidata RAVE, Oracle InForm and key technologies (e.g., SAS, Scanning/Imaging, IVRS/IWRS, ePRO)
- Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required
- Phase III experience
- Excellent communication, written and interpersonal skills
- Self-sufficient and able to work with minimal oversight
- Demonstrate leadership skills and the ability to lead teams and motivate team members
- Bachelor’s degree in a relevant scientific discipline or equivalent
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.