Senior Document Management Associate

Location: Ahmedabad, Gujarat, India

Apply

667

Workplace Type: On-site

The Senior Document Management Associate (DMA) is responsible for the maintenance of the Trial Master File (TMF), performing TMF Reviews, creating TMF Plans and TMF Indexes, and delivering internal and external TMF training.

Responsibilities: 

  • Assist the TMF Manager with creation of the study-specific TMF Plan and/or TMF Index as requested.
  • Process TMF documents in accordance with Advanced Clinical, Sponsor, and industry standards; includes document classification, metadata indexing, and Intake QC review.
  • Perform assigned TMF Reviews in accordance with the TMF Plan; includes creating requests for missing documents and following up with users on outstanding tasks.
  • Communicate TMF status to the TMF Manager, and report issues when identified.
  • Train persons on the use of Advanced Clinical Veeva Vault eTMF and related procedures, including providing guidance and training documentation.
  • Attend departmental and project team meetings as required.
  • Additional TMF responsibilities as requested by the TMF Manager.

Qualifications: 

  • Education – Associate or Bachelor’s Degree, or equivalent combination of education and experience.
  • Training – On-the-job or professional training in regulatory document collection and review. Demonstrated understanding of the CDISC TMF Reference Model filing structure.
  • Experience –
    1. Three (3) years industry experience working directly with clinical trial documentation.
    2. Experience with Veeva Vault or other eTMF systems strongly preferred.
    3. The ideal candidate has excellent organizational and time management skills and strong attention to detail, with an ability to maintain productivity and quality in a time-sensitive regulated environment.
    4. Must have ability to balance multiple projects simultaneously. Must possess strong computer acumen including proficiency with Microsoft Office suite and familiarity with clinical trial applications, including those used to manage and archive regulatory content.
    5. Possesses knowledge of and demonstrates ability to apply pertinent applicable regulations and guidelines pertaining to essential document regulations (e.g., ICH/GCP).
    6. Must possess knowledge of and demonstrate ability to apply pertinent applicable regulations and guidelines including Good Documentation Practice and Good Clinical Practice.

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.