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Job Details

Trial Master File Specialist

Company: SynteractHCR Deutschland GmbH
Location: Rockville, MD
Reference: 26873
Closing Date: 08 Dec 16
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Overview The Trial Master File (TMF) Specialist is embedded into clinical study teams, is the Trial Master File (TMF) study owner who ensures the actual maintenance of the study TMF by supporting the Study Delivery Lead (SDL) and document owners, and addresses ad-hoc issues.   Responsibilities Provide operational and administrative support for the study TMF management. Ensure high quality and up-to-date TMF management in clinical study teams.

Requirements:

Overview

TheTrialMasterFile(TMF) Specialistis embedded intoclinicalstudyteams, istheTrial Master File(TMF) studyownerwhoensurestheactual maintenanceof thestudyTMF bysupporting theStudy Delivery Lead (SDL)and document owners,and addressesad-hocissues.

 

Responsibilities

  • Provide operational and administrative support for the study TMF management.
  • Ensure high quality and up-to-date TMF management in clinical study teams. The role is embedded into several study teams.
  • Own and maintain the study TMF management plan and ensures adherence by the study team members
  • Support the SDL in planning and executing TMF management-related activities of the clinical trial team in order to ensure that the TMF is in good shape and updated on a timely manner.
  • Responsible to track eTMF-periodic reviews for studies and provide regular updates to the SDL/ Head TMF Operations
  • Primary point of contact for study team members for any TMF-related question
  • Support document owners to ensure TMF compliance.
  • In charge of the set-up of the TMF for each new study (on-boarding of study contributors, TMF plan, performing preparation of the documents in the system)
  • In charge, during the maintenance of the TMF that the contributors are providing their documentation on an in-stream basis (by running KPI, by running reports, by running QC checks if needed).
  • Take the appropriate relevant actions to address gaps, issues and risks
  • Provide training to newcomers and refresher training to existing users.
  • Act in a network across study and project assignments to make best use of location and time-zone
  • Collect study wet-ink paper documents, prepares the wet-ink documents for archiving, arrange shipments of those to the clinical archiving team for long term retention
  • May lead inspection/audit preparation related activities with regards to study-related documentation for studies in their Region providing documentation in timely manner and assisting with CAPAs as related to TMF finding in the region.

Qualifications

Academic & Professional Qualifications:

  • Graduate or Degree in administration, office management or scientific degree
  • Relevant working experience in pharmaceutical / scientific environment
  • Document management exposure is a definite requirement

Skills & Experience:

  • Clinical Document management exposure is a definite requirement
  • Scientific background and knowledge of clinical trials (including ICH-GCP) is an asset

What We Have to Offer

Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations

 

Who We Are

SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.

 

Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.

 

SynteractHCR’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with SynteractHCR must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.


Apply for this job: Trial Master File Specialist

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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