Job Title:  Manager

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

1. To determine whether all trial related activities were conducted, data recorded, analyzed and reported accurately & in compliance to all applicable Regulatory requirements, Organizational requirements (Policy, Procedures and processes) and Client’s requirements (protocol, contract etc.) by routinely conducting audits (In process, on-site and off-site) at various stages for all assigned projects.
2. To Function as a mentor, supervisor and guiding stature to junior team members and handle their training.
3. Participate in key internal project team meetings and facilitate quality discussions during these meetings, as appropriate.
4. To provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections
5. To support Head-QA/Designee for handling regulatory inspections and sponsor system audit, arranging data for regulatory inspection and sponsor system audit, responding to regulatory or sponsor queries pertaining to clinical trial/medical imaging issues, co-ordinate for regulatory/sponsor inspections/audits
6. To support Head-QA/Designee for quality analysis and trending tools. Tracking of open issues and drive towards resolution
7. Performing & reporting of system audits as per system audit annual calendar to ensure compliance w.r.to Lambda SOPs, Quality Systems, Protocol and applicable regulatory requirements.
8. To perform retrospective audits of study related raw data like Informed Consent Forms, project management plan and associated Plan, IMP plan, IMP release checklists, Safety Management Plan (SMP), Clinical Study Report.

EXPERIENCE

• 12 to 16 yrs. in Late Phase Quality Assurance.

EDUCATIONAL QUALIFICATION

• M. Pharm