Study File Specialist
King of Prussia, PA
We are currently searching for a skilled professional to join a well-known client’s team as a Study File Specialist in Pennsylvania. The Study File Specialist will provide support for Trial Master File (TMF) activities to the clinical teams. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Assist with implementing processes for Trial Master File (TMF) activities
- Liaise with study teams to facilitate knowledge and use of TMF tools and processes to standardize procedures
- Assist with implementation of the framework for a standard, global structure and maintenance of the Trial Master File (TMF)
- Use recent audit findings and consultant review to understand current status across sites, inconsistencies and gaps
- Continuous evaluation of electronic document repositories in use
- Use experience and knowledge of ICH GCP and Code of Federal Regulation Guidelines to design globalized standard structure for TMF
- Identify and develop templates, tools and processes for TMF set-up and maintenance
- Act as vendor liaison for standardized document filing across projects
- Collaborate with CQA and Clinical Quality Compliance team to ensure global submission and inspection readiness of TMFs as appropriate
- Perform TMF completeness reviews within the indicated timelines to ensure TMFs are inspection ready at all times
- Assist with reporting TMF related metrics to management
- Work closely with study teams fielding, escalating and resolving TMF related issues
- A minimum of four years of relevant clinical research (or related) experience within the pharmaceutical industry
- Experience in the set-up and maintenance of Trial Master File infrastructures and sound knowledge of regulatory requirements for global submissions
- Thorough knowledge of ICH guidelines, GCP and its applicability to all stages of the clinical development process
- Experience in oversight of vendors highly desirable
- Proficiency in MS Word, PowerPoint, Project, Excel, TMF related applications
- Bachelor Degree in a Business related discipline
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.