Careers – TMF Support Analyst

Mission/Goals:

•To provide internal and external teams with outstanding TMF
operational expertise and ensure deliverables with quality, on time, and
cost---effective with measurable services.
• To develop strong values and foster innovations in TMF process.
• To continuously improve performance and productivity (ensure high skill
level), and provide operational excellence through best practices and
lesson learned.

Position Purpose:

The Trial Master File Support Analyst is the Quality Control Expert and will
ensure TMF and documents accuracy and completeness. The clinical trial
documentation must be consistent with the Trial Master File Specifications,
submission/inspection readiness criteria and comply with LMKs (or clients)
SOPs and regulatory requirements. The TMF Support Analyst is to serve as
single point contact to the TMF Project Manager or equivalent to ensure a
complete and accurate TMF through documentation quality and consistency
across clinical trials and programs. The TMF Support Analyst may also serve
as a subject matter expert in Theralign commissioned projects.

 

Training & Education Preferred

Candidates for this position should have the following levels of
experience: Minimum of Bachelors Degree or equivalent required.
Clinical Documentation Management and industry experience to have a
thorough understanding of the processes associated with conducting a
clinical trials and document management operations.
• 1---2 years of Clinical Research Experience or professional equivalent
• 1---2 years of Document QC experience or professional equivalent

Role Description:

Position Title: Trial Master File (TMF) Support Analyst
Reports to: President and CEO/Vice President of Clinical Operations/Project
Leader/Project Manager
Location: Remote/Clients Office

Primary Duties

• Perform TMF and QC (Quality Control) and remediation across
functional lines.
• Scan and index documentation into the eTMF.
• Support teams during inspections or audits.
• Ensures documents maintained in the TMF are appropriate and the
content of those documents are accurate, complete and consistent
with LMKs (or clients) SOPs and regulatory requirements.
• To provide project teams with outstanding trial and data
management expertise/resources, and ensure deliverables with
quality, on time, and cost---effective with measurable services.
• To develop strong values and foster innovations in TMF
implementation, maintenance and good documentation practices.
• To continuously improve performance and productivity (ensure high
skill level and performance of staff), and provide operational
excellence through best practices and lesson learned.
• Ability to work in an international environment with internal and/or
external partners (CROs etc.)
• Strong English skills (verbal and written if English is the second
language)
• Ability to adapt and be flexible to change and managing internal and
external impediments