Lambda Therapeutic Research
Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA.
Job Title: Project Manager
No. of Posts: 1
Experience : 4 – 9 Years
Location : Ahmedabad
Salary: 7,00,000 – 15,00,000 P.A.
Job Description:
Project Management
- Prepare project plan as per the project timelines, budget and deliverables.
- Complete the assigned project in Qualitative, cost effective and time bound manner.
- Develop the contract and budget for clinical trial projects.
- Conduct feasibility studies.
- Track timelines, milestones and budget requirements for assigned projects
- Coordinate for the required regulatory submission and approvals for the conduct of the study and CTRI registration.
- Allocate CTLs/CRAs to clinical trial projects.
- System enhancement in terms of developing appropriate study tools and tracking system
- Assist new CTLs/CRAs in identifying and developing investigators for assigned studies.
- Co-ordinate planning and conduct of clinical trial projects in liaison with CTLs/CRAs and other interdepartmental team members.
- Assist in selection of the sites in conjunction with sponsor and lambda and recommend site assignments.
- Provide protocol specific training to the CTLs/CRAs including therapeutic expertise, CRF conventions, study procedures and SOPs
- Supervise activities of the CTLs/CRAs including the scheduling of monitoring visits, other activities associated with the project(e.g. review of visit reports for completeness and accuracy, assisting monitors with site problems etc and time accountability for the project.
- Conduct quality control and co-monitoring visits with CTLs/CRAs to ensure quality and compliance with SOPs, GCP and project requirements. Assist and guide CTLs/CRAs in conducting pre study, initiation, interim and close out monitoring visits as required.
- Review and approve payments to the study site and vendors.
- Prepare reports and updates for sponsor.
- Ensure effective communication between stake holders and all project team members.
- Guide the software team in developing e-CRF.
- Identify and screen newer sites and PIs.
- Identify the improvement areas in project management team
- Create database of new PIs and sites.
Human Resource Management:
- Effectively manage, motivate and motivate Clinical team leads and Clinical Research Associates.
- Ensure all necessary training is provided to improve their job performance, knowledge and make sure all day to day management support is provided(accompanied and training visits)
- Ensure Clinical Research Associate (CRA) meet quality/performance metrics for study and production of project metrics as required and devise specific tracking tools to ensure this is achieved.
- Evolve usage, working time and produce reports for clinical project managers.
- Supervise, evaluate and monitor workload of CTLs/CRAs periodically.
- Ensure monitoring frequency is met and reports in files are up to date.
- Review and tracking of visits, reports and follow up letters together with review of all significant communication with sites.
- Review and approval of expense claims, travel allowances, travel request forms and vacation requests according to the respective company procedures.
- Identify and implement development plan for CTLs/CRAs.
- Conduct performance reviews and provides continual feedback to team.
- Line Management of New Joinees, CRAs/Sr. CRAs/CTLs for CTM
- Establish regular communication with Sponsor, Clinical Research Associates, Clinical Team Leads and Clinical project Managers (Particularly those in other offices) via Telecom, email, local meetings, One on One meetings.
- Ensure timely and accurate dissemination of information to all team members
- Lead team communications and ensure meeting minutes are prepared and distributes.
- Any other responsibilities as assigned by the Management / HOD.
Qualifications:
Education:
UG -B.Pharma – Pharmacy
