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We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Mehsana (India), Toronto (Canada), Warsaw (Poland), London (UK) and the USA with approximate 750 employees located in our facilities across the globe.
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Lambda offers full-spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain is executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality in order to help clients develop products safely, effectively, and quickly.
Delivering the best is accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That’s why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team.
Position: Project Manager – Clinical Trials
Location: Ahmedabad, Gujarat
JOB RESPONSIBILITIES:
- Prepare the project plan as per the project timelines, budget, and deliverables.
- Complete the assigned project in a 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 the 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 closeout monitoring visits as required.
- Review and approve payments to the study site and vendors.
- Prepare reports and updates for the sponsor.
- Ensure effective communication between stakeholders 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 the project management team
- Create a database of new PIs and sites.
- Any other responsibilities as assigned by the Management / HOD.
Qualification: B.Pharma/B.Sc
Experience: 7-12 Years
Salary: 9,00,000 to 15,00,000 INR (CTC/PA), Medical Insurance – Self + 3 Family members
Contact Details:
careers@lambda-cro.com
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