Clinical Data Manager
We are currently searching for a skilled professional to join a well-known client’s team as Clinical Data Manager in Boston, Massachusetts. The Clinical Data Manager role will maintain quality and accuracy of the database for a clinical study, and will be responsible to communicate with client representatives and the programming team regarding database and programming needs/issues throughout the study. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- First and second pass entry of Case Report Forms (CRFs) and Data Clarification Forms (DCFs), Quality Control (QC) checks, Data Management Review (DM Review)
- Create study documents including materials for conducting regularly scheduled meetings with the client
- Follow Standard Operating Procedures (SOPs)
- Perform QC checks using applicable browser or reporting tools
- Participate in client study kickoff and closeout meetings
- Prepare study set-up including reviewing documents (CRFs, DMP, DCP)
- Complete user acceptance testing on the database and edit checks
- Conduct DM Review utilizing the DMP and DCP
- Perform vendor data reconciliation with applicable clinical database, issuing queries and tracking all DM issues to ensure proper resolution by study completion
- Identify data trends and inconsistencies, then follow up with a plan of action
- Communicate with client representatives and the programming team regarding database and programming needs/issues throughout the study
- Assist with final QC reviews and data listing audits
- Perform database freeze/lock and coordinate all related activities
- Perform first and second pass entry following the DMP and client conventions
- Creation and review of SOPs and training materials
- Experience in maintaining quality and accuracy of a database for a clinical study in the pharmaceutical industry required
- Experience with regulatory guidelines relevant to clinical documents, including Case Report Forms, Data Clarification Forms, and other similar documents required
- Experience in ensuring quality and accuracy of clinical study database required
- Bachelor’s Degree or Associate’s Degree required
- Training is required in the following subjects: Applicable Standard Operating Procedures, Good Clinical Practices (i.e. GxP Regulations; ICH Guidelines; Good Quality Practices), 21 CFR Part 11 and Computer Security, HIPAA, Drug Development and Approval Process, Data Management Overview, Sponsor/Study specific trainings, and Applicable System training
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.