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Job Number: 476719

Senior TMF Specialist

OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as Senior TMF Specialist in Cambridge, Massachusetts. The Senior TMF Specialist role will review company TMF documentation prior to filing in the TMF and if issues and/or discrepancies are identified with TMF content, remediate directly with company functional teams. Their work will have a direct impact on not just the organization but also on the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Implement quality content reviews, comprehensive completeness, and file TMF documentation to the TMF Reference Model filing structure
• Ensure company is ‘inspection ready’ at all times and trial master file documents are filed in a timely manner, in accordance with metrics timelines
• Confirm documents which fail quality review are effectively remediated and indicated as resolved/closed via tracking mechanisms prior to filing in the TMF
• Perform a close out review of study TMF and remediate any findings in preparation for study TMF closure
• Promote inspection-ready TMF’s and perform real-time updates as information is received
• Represent TMF Operations at study team meetings, participate in collaborative efforts, and play an important cross-functional role in TMF document retrieval and management
• Provide support to TMF Operations during audits and/or regulatory inspections
• Establish accurate and current study TMF information
• Liaise with Inspection Readiness Specialists to reconcile trial master file documents
• Identify trends and escalate concerns to TMF Manager and/or Head of TMF Operations
• Adhere to TMF SOP’s, KPI’s, and relevant TMF processes

EXPERIENCE

• Minimum of 4 years of clinical research experience required
• Minimum of 3 years of relevant document management, quality content review, and comprehensive completeness review experience required
• Experience in TMF required, including experience in study start-up, maintenance, close-out, and performing quality control and comprehensive completeness reviews
• Extensive knowledge and application of TMF Reference Model, ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R2) guidelines
• Detailed knowledge of clinical study file documents, clinical trial activities, and terminology
• Strong knowledge of Core, Country, and Site level files and corresponding expected documents per level
• Proficient in the ability to navigate multiple electronic TMF systems and advanced proficiency in Word, Excel, and PowerPoint
• Excellent organizational and communication skills

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.

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.

It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, 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.