Senior TMF Associate

• Document Classification and Review:

  Manage the document classification under Smart Inbox, ARC review, and deletion processes for clinical trials. This includes ensuring all clinical study documents (trial, country, and site artifacts) are uploaded, classified, and reviewed correctly in the eTMF system.

• Audit Readiness:

  Ensure that the eTMF is maintained in a state of audit readiness by performing visual quality checks on e-documents before they are released, ensuring clarity and readability, and conducting audit-ready checks on each document uploaded to ensure it is contextually accurate.

• Regulatory Compliance:

  Process and track essential artifacts throughout all phases of the study in alignment with company SOPs, sponsor SOPs, Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) guidelines.

• Operational Issue Resolution:

  Identify and resolve any operational issues related to the TMF, ensuring the proper preparation for internal and client audits. Implement corrective actions in response to audit findings.

• Collaboration and Communication:

  Work closely with internal teams and external partners to ensure client satisfaction and to support the timely and efficient completion of clinical trials.

• Training and Mentorship:

  Provide training and mentorship to other team members, supporting continuous improvement and knowledge sharing.

• Business Process Improvement:

  Contribute to business improvement initiatives focused on driving quality, enhancing productivity, and streamlining processes.

• Meeting Participation:

  Attend internal and external study team meetings as required to support the project s documentation needs.

Qualifications:Minimum Required Qualifications:

• Education:

  Bachelor s Degree in Life Sciences, Business, or a related field.

• Experience:

  A minimum of 3 to 6 years of experience in a clinical research environment, with a solid understanding of clinical document management and eTMF processes.

• Knowledge:

  Strong understanding of GCP, ICH guidelines, and regulatory/clinical document requirements.

• Technical Skills:

  Proficiency in Microsoft Office, web-based applications, Adobe Acrobat Standard, and the ability to apply software tools related to document management, scanning, and eTMF systems.

• Communication:

  Excellent interpersonal and communication skills, with the ability to work collaboratively in a team environment.

Preferred Qualifications:

• Advanced Education:

  Master s Degree in Life Sciences, Business, or a related field.

• Experience:

  Additional experience in clinical electronic systems and eTMF platforms.

• Knowledge:

  Familiarity with clinical trial processes, regulatory documents, and audit preparation.

Physical Demands / Work Environment:

• Travel:

  Minimal travel required (less than 10%) for Sponsor Kick-Off Meetings, Client Meetings, or as requested