Work Experience

Min 7 years of expereince in studies inlucding BA/BE, Phase 1- 4 in reputed CRO/Pharma company. 

Handled CR team of minimum 2 for at least 3-4 years. 

Job Description

To lead the team of CR for planning & conducting clinical research studies & Acts as the primary contact for vendors to lead in planning and communication with cross funtion teams ensuring effective conduction of  clinical studies (BA/BE, Phase I-IV).

To review of medical records, interviews, screenings, and discussions with CRO for eligibility & feasibility. To take care of safety of patients, non-breaching of contract, procedures, and data integrityPreparation, review, analysis & summarizing of all documents/reports that are related to clinical projects, which includes contracts, RFP, vendor budgets for regulatory & financial needs.

To monitor and report on the progress of delegated clinical trials, which includes budgets and timelines.

To oversee the pattern and manner in which clinical research study is being conducted to esnure sucessful completion of the projects as per decided  TAT , Milestone & Qaulity parameters. 

To attain clinical study’s goals by working with other members of the study team to outline their priorities, and to also resolve conflicts & ensuring overall procedural & Quality improvement.

To conduct regular audits at sites/CRO for GCP compliance, correctness of data and taking CAPA. Ensuring all the documents are updated and  archived on regualr basis including SOPs and payments. 

Education Doctorate in PharmacologyMasters in Pharm D DegreeCompetencies Customer CentricityStrategic AgilityDeveloping TalentCollaborationResult OrientationStakeholder ManagementInnovation & CreativityProcess Excellence