Manager, Trial Master File
At Advanced Clinical, we’re excited to share with you a great opportunity at growing organization for the position of Manager, Trial Master File in Edison, New Jersey. The Manager, Trial Master File will be responsible for ensuring completeness, quality and accuracy of assigned Trial Master Files for clinical trials and ensuring they are ready for inspection. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Establishes relevant procedures and processes, and performs quality control review for study documents, as well as aggregated regulatory data included in regulatory submissions
- Represents TMF Operations in internal and external meetings involving management of clinical study TMFs
- Performing quality control checks on documents generated by all functional groups and place in the QC workflow
- Effectively communicating internal compliance metrics with managers and other colleagues within clinical and regulatory operations as well as affiliates and CRO(s) performing Trial Master File tasks on behalf of Company, to improve and maintain data quality for studies
- Manages TMF Operations contractors to ensure compliance with established TMF management procedures and policies
- Provide leadership and work guidance to both internal personnel and contractors, remotely located contractors, and CRO or vendor staff to answer questions, triage problems and requests regarding system support issues
- Responsible for assigned TMF process improvement initiatives and implementing new processes utilizing key technologies
- Six or more years of experience in information or document management in an end user computing environment
- At least 3 years of experience working with clinical trial documentation
- Experience working with records management and archival procedures
- Experience working with validated system implementations and Pharma or Health Care organizational processes
- Experience working in an eTMF system is preferred
- Versed in managing hosted computing environments and strong vendor’s management expertise
- Bachelor's degree in life sciences, business, or related field preferred or equivalent combination of education and experience
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.