Associate Director, Clinical Data Management

Company: Advanced Clinical
Location: Somerville
Posted on: January 6, 2021

Job Description:

OVERVIEW We are currently searching for a skilled professional to join a well-known client---s team as an Associate Director, Clinical Data Management in Cambridge, Massachusetts. The AD, Clinical Data Management role will handle and manage data management (DM) activities for all phases of clinical trials (Phase 1-4), oversee CRO DM activities, and manage the quality of DM deliverables. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES Provide leadership and contribute to strategy decisions regarding DM solutions Oversee the DM external service providers Report status updates, resolve disputes, and ensure timely acquisition of high-quality deliverables from the external service provider Participate in and oversee study setup and initiate procedures such as CRF design, database design, edit check design/review, DMP (Data Management Plan) review/approval, and annotated CRF design Ensure accuracy, completeness, and consistency of clinical trial data Initiate and develop new and more efficient processes and procedures for study setup, maintenance, closure, and archiving activities to meet business needs Develop and implement changes to DM guidelines and quality processes to a standard, accurate, complete and consistent format conducive to analysis and regulatory submissions Coordinate the acquisition and development of tools to support DM internally and externally with DM vendors Contribute to budget forecasting, cost accrual processes, and communicate to the team any budgetary impacts of decisions or processes implemented to achieve results Create optimal relationships with internal customers, colleagues, and strategic partners/vendors Mentor team members, junior staff, or contractors EXPERIENCE Minimum of 8 years of experience as a Data Manager in a CRO or pharmaceutical/biologics/biotechnology company required Experience as lead CDM managing studies from start-up through close-out required Experience with managing direct reports preferred Ability to communicate DM standards, developments, and challenges to both internal and external audiences Detailed understanding of DM responsibilities and project activities (i.e. budget, timelines, resources) Good knowledge of all study phases and large, complex clinical programs Knowledge using metrics to determine project status, monitor internal/external DM team progress, plan for project resources, and monitor project budget Strong technical knowledge to apply to work activities Demonstrated proficiency in efficient database and/or SAS dataset design preferred Knowledge of ICH, GCP, industry practices, and standards (CDISC, SDTM, CDASH) Excellent written and oral communication skills EDUCATION Minimum of Bachelor---s Degree required, in a scientific discipline preferred 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. It is Advanced Group---s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Keywords: Advanced Clinical, Somerville , Associate Director, Clinical Data Management, Healthcare , Somerville, Massachusetts