Document Management Associate (TMF /Oncology) - 1 Year Contract – Hybrid- NC Pharma

Our client, an RTP-area Biopharmaceutical company with products in the oncology and severe disease space, is actively recruiting for a highly skilled and knowledgeable Trial Master File (TMF) expert for a 1 year contract on its Clinical Operations Team.   

 This company is building and has a solid pipeline with a strong focus in the oncology space.  This Document Management Associate will be responsible for the TMF, to include conducting TMF quality reviews, maintaining assigned study trackers, and ensure documents maintained are appropriate and adhere to regulatory standards.

The selected candidate will be involved in performing essential document review ensuring sponsor obligations are being met and follow applicable regulatory, ICH/GCP guidelines and SOPs.

 This role is Hybrid, work from home with occasional travel to the RTP area office.  The ability to drive in to the office as needed will be required.

Key Things to Note:

• This is an established NC-based BioPharma with a growing and impressive pipeline
• This Document Management Associate will ensure TMF completeness, at study, country and site levels by facilitating the collection and review of documents with the study team
• This role will work with CRO partners and support the migration of external TMFs from CROs/Vendors
• This is a highly collaborative role involving regular interaction with cross-functional team members, clients and vendor partners.  Right candidate will complement broad and deep knowledge of clinical operations with strong communication and interpersonal skills.

 Responsibilities will include:

• Participate in the Quality Control of documents submitted to the eTMF
• Maintain awareness of study events and the associated documentation requirements through collaboration with the TMF Manager/Lead and the Study Team (including CRO if appropriate)
• Assist in review of regulatory and other essential documents for completeness and accuracy, initiating follow-up as needed for issues and deficiencies.
• Communicate any document inconsistencies (GCP or ALCOA+) back to the Functional area or Document Owner for resolution.  Identify any corrective actions which must be addressed/assigned; collect missing and expired documents; and resolve eTMF discrepancies
• Support the management of eTMF documentation issues throughout the lifecycle of a study
• Track versions, submissions, approvals, etc., as applicable, for all essential trial documents and work with project staff to address any holes
• Proactive management of clinical documentation and trackers
• Support regulatory submissions through providing appropriate TMF documentation
• Maintain an audit-ready eTMF

 Targeted candidates will offer an Associates or Bachelors degree, to include 3-5+ years of TMF management.  Experience in a Pharma / Biotech / CRO will be required.  Experience working with and overseeing CRO partners will be a strong plus. 

 Other priorities include:

• Knowledge of the DIA Reference Model, ALCOA+ standards, Good Documentation Practices, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and Food and Drug Administration (FDA) and/or EU guidelines will be needed.
• Experience working with documents at study start-up, during study conduct and close-out will be required
• Experience in handling TMF documents during a regulatory inspection will be a plus. 
• Proactive and smart organizational skills
• Excellent documentation skills and detail-orientation

 This is an immediate need.  Please forward Word resume for prompt consideration.