Assistant-Trial Master File Project Management
India, Bengaluru
Full time
R-27208

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.


Clinical Trial Essential Document Responsibilities

Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified
Complete administrative tasks (e.g., status reports) as requested
Participates in study specific training as required.
Evaluate and tailor the expected documents (ED) to ensure proper tailoring has been assessed to make a trial specific TMF.
Evaluate the TMF records prior to finalization, as appropriate.
Communicate directly with functional areas for proper hands-off to occur during the start-up, maintenance, and close-out of the trial.
Identify, communicate, and resolve issues.
Ensure appropriate functional check oversight activities occur for all functional areas.
Ensure appropriate archiving of clinical trial documents to meet Lilly record retention policies and regulatory requirements.
Understand, comply, and reinforce local regulations and guidance, Lilly medical policies and procedures, and good clinical practices (GCP)
Ensure inspection readiness through a complete, accurate and readily available Trial Master File.
Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified

Minimum Qualification Requirements:

1-2 years’ experience with clinical development processes
Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable
Experience in document administration
Knowledge of cGCP
High attention to detail
Excellent organizational skills
Strong written and verbal communication skills; and Proficiency with MS Office/Adobe Acrobat
Experience in working with electronic trial master files strongly preferred
Demonstrated critical thinking capabilities with forward looking perspective and comfort with ambiguity.

Other Information/Additional Preferences:

1-2 years TMF experience a plus
Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired
Ability to learn and comply with regulatory requirements and internal policies​
Effective communication, teamwork and problem-solving skills​
Self-management and organizational skills​

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[ Article by: team tosscall ]