Clinical Data Manager
At Advanced Clinical, we’re excited to share with you a great opportunity at growing organization committed to clinical excellence for the position of Clinical Data Manager. The Clinical Data Manager is located in Stamford, Connecticut, and is committed to providing data management support for the clinical development plan while maintaining high quality standards and ensuring compliance with all applicable regulations and guidelines. As they support the expanding Clinical Trial portfolio and take the lead on one or more studies, 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 oversight of data management CRO activities supporting clinical programs from database start-up through database lock and CSR/submission
- Serve as primary point of contact with the DM CROs, 3rd party vendors and internal study teams
- Work with internal team and DM CRO to develop study timelines and ensures all DM related deliverables are met
- Oversee the development of the clinical database (DB), including user requirements, edit rules/checks, query logic, and data validation
- Manage the development of key data management documents, such as case report forms (CRF), data validation specifications, manual data review guidelines, programmable edit checks, and Data Management Plans (DMP)
- Ensure compliance with above listed study documents
- Participate in review of clinical research documents (e.g. Protocols, Safety Monitoring Plans, Communication Plans)
- Work with CRO to ensure the clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock
- Organize study specific meetings (e.g. Protocol Deviation review. Medical Data review)
- Develop, track, analyze, and report, as applicable, on data management performance metrics
- Assist in the preparation and oversight of study audits/inspections, both internal and external
- Develop and/or revise Data Management SOPs, work instructions, and templates/standards incorporating the industry’s best practices and any applicable regulatory guidelines and requirements
- Minimum 5-7 years required in data management or related work in pharmaceuticals
- Experience with CDISC/CDASH, including the SDTM model required
- Experience with standard international coding dictionaries (e.g. WHODD, MedDRA) required
- Experience required with various EDC software, such as Medidata RAVE, Medrio, Oracle, Inform
- Experience working with CROs and with vendor oversight required
- Experience in partnering with various functions such as Clinical Operations, Medical, programming, and Biostatistics required
- Work experience required with Phase I-IV study trials
- Knowledge of Good Clinical Practices, Clinical research, Clinical Trial process and related regulatory requirements and terminology required
- Knowledge of regulatory agency such as the FDA, EMA, PMDA and audit experience preferred
- Bachelor’s Degree required, preferably in science related field or computer systems/IT
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.