Axios Clinicals
CAREERS
Associate Director, Clinical Data Management
OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team in Cambridge, Massachusetts as an Associate Director Clinical Data Management. This remote role will lead the Clinical Data Management Team and oversee the operational and administrative execution of clinical trials. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
EXPERIENCE
- Minimum of 12 years of experience in Clinical Data Management with some oversight of DM activities as a Lead required
- Excellent knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects
- Experience with Clinical Database Systems and processes
- Experience in leading teams and resource planning
- Good written and spoken English with effective communicative skills
- Ability to motivate/lead a team, work under stressful conditions, recognize problems, and provide solutions
- Proficient in MS software (Word, Excel, and PowerPoint)
- Experience with at least one Clinical Data Management System (Medidata, OCRDC, Inform, etc.)
EDUCATION
- Minimum of Bachelor’s Degree required
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
- Organize and conduct team meetings
- Oversee team development, identify high-performance team members, and work on team development together with the (Senior) Director Clinical Data Management
- Assist project teams with the oversight/supervision of CRO/third party vendors and organize trainings as needed
- Serve as a mentor for new incomers or delegate to appropriate team member this activity
- Offer continuous feedback to develop team members
- Contribute to the development and review of portfolio documents
- Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, CDM guidance documents (where available)
- Identify needs of new technology/tools for Data Management and take active role during development/implementation
- Supervise clinical data management activities within portfolio/platform program and ensure it is per company standards/strategy
- Escalate unresolved data or compliance issues to functional manager(s)
- Provide guidance to Subject Matter Experts regarding standard process developments
- Ensure trial processes are aligned within assigned portfolio/platform program(s) and escalate any deviations/unforeseen non-compliance
- Represent portfolio/platform program(s) team in cross-functional interactions and problem-solving
- Participate in strategic vendor selection/relationship management processes for Clinical Data Management
- Input to the developing, revising, and maintaining core operating procedures and templates
- Support/assist Quality Assurance department in conducting audits involving data management activities
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.
If you need urgent support, simply call our 24 hour emergency hotline.
Your personal case manager will ensure that you receive the best possible support.
Call Now (toll free)