Assistant Clinical Project Manager/ Clinical Project Manager Job in Aurigene Discovery Technologies Limited

Desired Profile

M. Pharm / M.Sc. with 1 - 2 years of experience as CTL or 4+ years of experience as Sr. Clinical Research Associate

Job Description, Key Skills and Competencies:

Perform site selection, monitor and ensure trial close out and retrieval of trial materials. Also, participate / review reports from site visits. Operate at project level under joint supervision of respective Project Manager(s) and responsible Clinical Operations Manager. Work with team to adapt, drive and track subject recruitment plans. Lead / assist study-related training of CRO personnel (CRAs & study site team members). Contribute to the development and update project planning documents, essential study documents and project manuals/ instructions. Foster team spirit and productivity by establishing communication lines within the project team. Mentor junior team members, share knowledge & best practices and support other CRAs. Conduct clinical trials in accordance with country s regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures. Evaluate the quality and integrity of CRAs/other team/study site members practices related to the proper conduct of protocol and adherence to applicable regulations. Manage the progress of assigned studies by tracking regulatory submissions & approvals, recruitment & enrolment, case report form (CRF) completion & submission and data query generation & resolution. Responds to company, client and federal regulatory requirements / audits. Create and maintain appropriate documentation related to site management, monitoring visit findings and action plans. Collaborate and liaise with study team members for project execution support. Maintain and keep administrative tasks (such as expense reports) updated. Assist project team to prepare project publications / tools and share ideas/suggestions with team members. Perform additional study tasks as assigned by the Project Manager (e.g. visit report review, CRA performance review, lead CRA calls etc.). Competencies: Communication Skills Interpersonal Skills Team Player