Axios Clinicals
CAREERS
Manager of Clinical Data Management
OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team in Cambridge, Massachusetts as a Manager of Clinical Data Management. This remote role will lead clinical data management activities that support company studies across all stages of clinical development. Their work will ensure that clinical data capture, systems, and processes produce accurate, consistent, high-quality, and complete data. Apply now to talk to one of our recruiters and learn more about this progressive career opportunity.
EXPERIENCE
- Minimum of 5 years of progressive experience in clinical data management in a regulatory environment required
- Demonstrated proficiency managing the lifecycle of clinical data projects
- Experience developing reports using J-Review, BOXI, and/or other CDM reporting tools
- Experience with EDC databases, including Oracle Inform and/or Medidata Rave
- Experience with CDASH/SDTM/CDISC standards
- Experience working with central and specialty labs/vendors
- Good working knowledge of medical terminology and medical coding dictionaries (MedDRA and WHO)
- Understanding of GCP, ICH, and FDA requirements as applicable for Clinical Data Management
- Ability to manage multiple initiatives and shifting priorities within a small, fast paced company environment
- Strong analytical and problem-solving skills
EDUCATION
- Minimum of Bachelor’s Degree in a health-related field required
- Master’s Degree 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.
RESPONSIBILITIES
- Plan, coordinate, and manage data management tasks/timelines
- Act as primary liaison with CROs, third party data vendors, and EDC vendors
- Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed
- Primary author/approver for CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, Data Management Plans, and third-party vendor data specifications
- Oversee database design, production, and UAT cycles to ensure the CRO meets the highest quality standards
- Validate external data vendor documentation, management, and reconciliation
- Contribute to departmental SOPs, process development/improvement, and integration of technology
- Perform and/or review medical coding and SAE reconciliation
- Support internal review/QC of clinical data
- Assist with GCP inspection readiness
Regarding your application
Please know that every completed application is carefully reviewed by the our 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 our 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.
Please fill out the form below as it relates to the above job opening. A member of our team shall reach out to you thereafter. In the event you do not meet the criteria for the position, we shall notify you about relevant positions, and keep you in mind whenever we have the right opportunity for your skillset.
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