Project Manager - Clinical Trails

Job Description

Role & responsibilities Project Planning To collect primary details and timely prepare the feasibility & final proposal along with budgetary requirements in consultation with HoD. To prepare various templates for Project Management including elements like Monitoring Plan, Defining Team Members, Communication Plan, Escalation Plan, IP Handling Plan, Safety Management Plan, Risk Mitigation plan, Study Data Flow, Perform risk-assessment and execution plan for various client studies. Query resolution from clients and management, prepare a plan involving multiple stakeholders and its finalization. Plan and identify resource requirements, Project Monitoring & Co-ordination To perform a single point of contact between clients and internal stakeholders. To conduct periodic visits to various study sites, follow-up and coordinate for timely preparation of study documents (like protocol/ICF, CRF, Patient Diaries, etc.), disseminating milestones based on proposal and ensure timely achievement of the same. To co-ordinate for all start-up activities like vendor qualification, regulatory/EC submission and approvals, logistic, insurances, site identification and clinical trial agreements with them and creating all Study related plans, IP Management, ensure proper resource availability for the study and review various other study related requirements as per check-list. Project Review To undertake routine communication with the site Principle Investigators, attend periodic progress review meets with clients as well as sites and with internal stakeholders. To review all expenses and billing, /invoicing to sponsors, review the draft report and ensure timely submission of final report to sponsors. Audit & Compliance Be representative for all internal and external audits for COD studies, review and ensure timely responses to internal (QA/QC) and external (Sponsor/Regulatory) auditors. To prepare and keep updated the departmental SOPs and ensure compliance of the same. MIS To ensure update of all study specific progress MIS with milestones and commercials Team development & Team management Responsible for team development by mentoring and training. Responsible for approval of individual employees performance goals. Ensure the safety and well-being of departmental employees and provide assistance to resolve employee grievances. Responsible to approve leaves and attendance of team members. Reward and Appreciate employees to boost their morale Keep a check on departmental attrition and make efforts in reducing the same. Responsible to manage departmental work in absence of reporting manager. Any other task assigned by reporting authority.