Manager/Senior Manager, Document Control (Study Archivist)
Proclinical is currently recruiting for a Manager/Senior Manager of Document Control with a leading biotechnology company located in Stamford, CT. As the Document Control Senior Manager, you will be responsible for the completeness and accuracy of the Trial Master File (TMF) and non-clinical (GLP) records for all company sponsored ongoing studies and archival information.
- Collaborate with study team members to define the study file plan; TMF plan or GLP study record.
- Ensure each current study record is checked and filed per the approved file plan and is inspection ready.
- Define and maintain appropriate file placeholders within the paper or electronic filing systems in collaboration with study team members.
- Assist study team to resolve file errors and other items of noncompliance; track timeliness of documents to be filed within the electronic document file system (GLP records) or eTMF (Clinical records).
- Assess records and develop metrics for documents not filed per timing requirements (as defined in SOPs or regulations).
- Identify any non-compliance trends and escalate to management.
- At study completion, ensure the records are ready to be archived.
- Co-audits the long-term storage archives of original GXP documents (as assigned).
- Maintains the company Master Archival index per retention policies and regulation.
- Manage any document requests from Health Authorities and assist with the transfer of archived records from the vendors upon inspection request.
- Work proactively and prospectively with TMF contributors at Study, Country and Site level to ensure and track timely uploading of all Essential Documents as defined in the current version of ICH E6: Good Clinical Practice Guidance (ICH E6(r2).
Skills and Requirements:
- Bachelor's degree in an academic or scientific discipline.
- 7+ years of TMF, GLP laboratory documentation and/or document management experience is required.
- Knowledge and application of ALCOA-C standards, Good Clinical Practice, Good Documentation Practices.
- Prior managerial experience and ability to work in a multi-national team-oriented environment as well as work independently on assigned projects.
- A self-starter capable to independently manage multiple ongoing projects and handling tasks in a fast-paced environment and delivering results within tight timelines is desirable; experience working on a global study teams to achieve goals and meet success criteria within specified timelines.
- Must have knowledge of Core, Country, and Site level Essential Documents in global clinical trials; experience should include study start-up, maintenance, and study closeout, and performing quality and completeness reviews.
- Must have Subject Matter Expert knowledge of DIA TMF Reference Model, clinical trial activities and related terminology; able author study archival procedures.
- Must have ability to navigate eTMF systems and be proficient with Microsoft Windows and Office software.
- Working knowledge of change management; Veeva TMF and other document management systems is preferred; prior experience in systems implementations, upgrades and internal archival audits and regulatory inspections is a plus.
- Good communication and interpersonal skills, verbal and written, is required; leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams.
- Demonstrate ability to make decisions, deliver on commitments, share knowledge, acknowledge team member achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment.
If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 31 646-779-7968 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.