Clinical Studies Coordinator

18 hours ago

Pune, Maharashtra, India beBeeClinical Full time ₹ 1,04,000 - ₹ 1,30,878
About the Role

We are seeking a seasoned professional to manage the set-up, planning, and maintenance of clinical studies in our client portal. This individual will be responsible for maintaining a strong understanding of client conventions or client-specific database conventions as appropriate.

Key Responsibilities
  1. Manage the set-up, planning, and maintenance of clinical studies in the client portal.
  2. Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents, and directives.
  3. Participate in project team and internal meetings as necessary.
  4. Prepare and support coordination of ISR study files for archiving at completion of projects.
  5. Ensure that the IST investigator is providing study updates as applicable to the customer, including regulatory updates, enrollment data, and safety information transfer.
  6. Monitor eTMF compliance based on the eTMF filing plan and provide guidance to Investigator site staff via raised queries in the BMS FastTrack communication portal.
  7. Validate initial drug supply demand based on the Investigators enrollment plan and provide forecasting updates to BMS as required.
Requirements
  • Demonstrated experience in managing clinical studies, with a focus on set-up, planning, and maintenance.
  • Strong understanding of client conventions or client-specific database conventions as appropriate.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
  • Ability to analyze complex data and make informed decisions.
  • Familiarity with electronic trial master file (eTMF) systems and the ability to navigate them effectively.
Working Arrangements

This role will involve working closely with our investigative sites and other stakeholders to ensure the successful delivery of clinical studies. The ideal candidate will be able to work independently and as part of a team, with excellent communication and interpersonal skills.

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