Senior Clinical Data Manager
Our client is looking for a highly qualified and skilled professional for the role of Senior Clinical Data Manager (CDM) in Cambridge, Massachusetts. We are looking for a Senior CDM who will contribute to data management activities in support of studies across all stages of clinical drug development.
- eCRF development by leading cross-functional reviews of eCRF content
- Database build activities, including review of edit check specifications and performance of user acceptance testing
- Monitoring data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
- Oversight of database lock activities and ultimate archiving of study data
- Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance, and Regulatory Affairs; CROs, central and local laboratories, and other vendors
- Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
- Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation
- Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
- Participate in the drafting and review of timelines consistent with company goals and ensure all deliverables and milestones are met
- Review clinical protocols and amendments, clinical study reports, statistical analysis plans, etc.
- A minimum of seven years related experience in a pharmaceutical, biologics, or biotechnology company
- Experience working in an outsourced Data Management model
- Expert knowledge of eClinical processes, efficient design and build of an electronic data capture (EDC) system
- Knowledge and understanding of regulations and industry-adopted data standards such as CDISC SDTM and CDASH
- Oracle InForm and Medidata Rave; Experience using standardized medical terminology, including MedDRA and WHODrug
- Experience working with MS Office Suite (Excel, Word and PowerPoint) and familiarity with MS Project
- Understanding of ICH GCP as well as general knowledge of industry practices and standards
- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
- Bachelor’s Degree in scientific discipline, Master’s Degree or equivalent 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.