Contract TMF Specialist

A leading biotechnology company that specialises in RNAi therapeutics is advertising a vacancy for a Contract TMF Specialist position. The organisation uses this innovative form of therapy to treat rare genetic, cardio metabolic, acute hepatic infectious, central nervous system (CNS) and ocular diseases. The Contract TMF Specialist will join this company in their office in Berkshire. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.

The Trial Master File Specialist will be responsible for providing oversight of all electronic and paper Trial Master Files. They will work closely with study teams to provide expertise in record management and archival support for Clinical Operations. This position is for a 12 month rolling contract period.

Job Responsibilities:

• Process Clinical Operations' administered TMF records: against pre-defined quality criteria and in compliance with service levels
• Work closely with study teams to aid them in completion of study specific TMF Plans
• Resolve Clinical Operations' administered TMF-related queries or quality issues by working with study teams
• Shared responsibility of monitoring TMF mailbox
• Ensure completion and accuracy of Clinical Operations' administered TMF at all times and provide advice to study teams with respect to the filing of TMF records
• Perform assigned TMF review actions in a timely manner
• Support Clinical Operations' preparation for a TMF audit or inspection (i.e. inspection readiness)
• Prepare for receipt of CRO's portion of the TMF
• Process the CRO's portion of the TMF in a timely and controlled manner in accordance with procedures
• Prepare Clinical Operations' administered TMF records for long-term, off-site archival in compliance with company and expertise area-controlled procedures and GCP
• Archive Clinical Operations' administered TMF records in a timely and controlled manner in accordance with procedures
• Retrieve Clinical Operations' administered TMF records from long-term, off-site archival
• Perform quality checks and test retrievals of Clinical Operations' administered TMF records from long-term, off-site archival; document any findings and follow to resolution or escalation in compliance with company and expertise area-controlled procedures and GCP
• Support and train Clinical Operations' team members on the eTMF system and corresponding work procedures
• Continuous assessments of Clinical Operations' record management work practices in order to maximize efficiency; communicate to management any improvement suggestions
• Participate in independent audits of external archive facilities, as applicable
• Control access to Clinical Operations' administered TMF records, filed or archived, in accordance with procedures
• Manage, track and document TMF records received, filed, archived, retrieved, transferred and destroyed in compliance with company policies

Skills and Requirements:

• Four years related experience in biotech/pharmaceutical industry in the clinical environment.
• Solid working knowledge of the TMF Reference Model.
• Strong Record Management skills/
• Good knowledge of Good Clinical Practices (GCP), regulations/guidelines and of the auditing process and compliance requirements/
• Veeva eTMF experience preferred but not mandatory/
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at +44 207 440 0639 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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