Senior Trial Master File Specialist

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Apex Systems
Computer, Management, Systems
Full Time

Job Description

Senior Trial Master File Specialist 1198706

Job Scope and Purpose:

Our Cambridge based biotech client is seeking a motivated Sr. TMF specialist to join their growing team. The incumbent will be responsible for supporting the set-up, maintenance, and archival of the study Trial Master File. Applicants should have prior experience with performing periodic study-level TMF quality, completeness, and timeliness reviews at defined timepoints to ensure adherence to TMF Specifications, ALCOA+ standard, company SOPs, ICH/Google Cloud Platform guidelines, Regulations, and industry best practices. If you consider yourself a TMF guru and want to join a fast-paced team with great leadership and great culture, continue reading and consider applying today.

Primary Job Requirements:
  • Bachelor's Degree or its International Equivalent in Computer Science, Life Science, Health Science, or Information Management desirable but not mandatory.
  • Minimum 5 years of pharmaceutical industry experience related to document management/TMF.
  • Experience with Veeva Vault Clinical (eTMF) preferred.
  • Experience working with the TMF Reference Model and ALCOA+ standard.
  • Experience performing QC of TMF documents and CRO oversight QCs.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

achan@stratacuity.com

Code: ClinOps

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .


Company Information

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. We provide a continuum of service from workforce mobilization and modern enterprise solutions to digital innovation to drive better results and bring more value to our clients. Apex transforms our customers with modern enterprise solutions tailored to the industries we serve. Apex has a presence in over 70 markets across US, Canada and Mexico. Apex is a segment of ASGN Inc. (NYSE: ASGN)

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Dice Id : apexsan
Position Id : BHJOB2374_1198706
Originally Posted : 3 months ago

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