This is an exciting opportunity to join Phlexglobal, an expanding specialist provider of Trial Master File document management solutions to the global clinical research market, as a Trial Master File (TMF) Study Owner working onsite at a client location in Boston.
In this key role, the TMF Study Owner (SO) is the subject matter expert to and single point of contact for the Project Manager (PM) or equivalent and Study Team to ensure a complete and accurate TMF through documentation quality and consistency across clinical trials and programs. The TMF SO is accountable to the PM or equivalent for all global trial master file responsibilities conducted internally as well as externally at the Alliance Partners (APs) and Contract Research Organizations (CROs). TMF SOs provide crucial TMF quality support to the Study Team and are expected to establish a proactive quality-focused partner-relationship with the Study Team.
A full job description will be provided ahead of interviews but in brief, your role will include:
- Contribute to the development and assist with the implementation of the TMF specifications, such as process and system changes.
- Lead the set-up of the TMF Study Specific Document List (SSDL) and monitor completeness and quality of TMF content for all assigned clinical trials until study close out.
- Ensure documentation flow is within projected timelines and determine course of actions to prevent and remediate delays/slippages.
- Ensure consistent use of standardized processes and technologies across clinical trials and programs. Determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.
- Assess impact of potential changes to TMF specifications prior to implementation; collaborate with PM or equivalent if modifications are necessary.
- Maintain Study Specific Document Lists (SSDLs) at the study, country and site levels by collaborating with all relevant Functional Lines (e.g. Data Management, Clinical, Regulatory, etc.) to ensure placeholders are correctly and accurately in place for the study and all versions and instances are filed in a timely fashion.
- Support the preparation of appropriate audit and inspection responses.
We are looking for individuals who have:
- Experience in management of medical/clinical study records and documentation.
Experience/knowledge of ICH/GCP documentation requirements.
- Clinical Documentation Management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
- Experience with the following application types: Electronic documentation management systems, web based data management systems, as required, and database utilization
- History of achievement in building strong customer relationships. Strong skills in negotiation and conflict resolution essential.
- Ability to remain calm and focused in high-stress situations is very important.
The ideal candidate will:
- Be able to work independently, prioritize and seek input where necessary
- Have excellent verbal and written communication skills
- Have (at least) intermediate skills in MS Word, Excel, PowerPoint and Outlook
- Be able to demonstrate a flexible, proactive, diligent and self-motivated approach to work
- Be able to travel/work internationally for training/as required
To apply, please complete the below application.