Country: India / Chennai ROLE PROFILE
General (organization chart to be attached)
Job Title: Project Manager
Department: Project Management Team
Reports to (Job Title): Vice President/ Head of Clinical Operations & Project Management
Job Purpose (State in one sentence the overall objective of the role)
Project Manager (PM) is responsible for the management of all aspects of Clinical Trial activities for assigned project(s). The Project Manager is accountable for achieving successful delivery of Clinical projects as per company standards and regulatory requirements. He/ She will be responsible for consistency delivery of the projects with adequate resource utilization.
Major Activities(Describe the 5-7 main results of the role to be achieved )
� The overall efficient day to day management of the trial.
� Regular liaison with clients, third party vendors for the successful delivery of the projects.
� Provide efficient updates on trial progress to the Function Head with respect to vendor selection, project plans, trial budget, site management, trial execution & overall information related to the projects.
� Develop and administer study budgets.
� Assist in preparing& reviewing of critical study related documents like Protocol, IB, ICF, DMP etc
� Maintains frequent contact with study investigators & site team
� Provide guidance, clinical trial management expertise, and direction to internal team
� Liaison with the Trials Steering Committee, Data Monitoring and Ethics Committee with a view on compliance a per ICH- GCP, Data Protection and Ethical Requirements.
� Monitor/audit clinical sites for adherence to protocol and GCP, including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits, co-audit visits as per requirement.
� Lead Audit& Inspection readiness in projects
� Assurance of regulatory compliance of investigational sites with company SOPs, EMA/FDA and ICH guidelines.
� Review and/or submission of research ethics committee/regulatory documentation
� Lead recruitment & retention of the study subjects & meet timeline as per the SLA with clients
� Identify, select and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits.
� Ensure studies are carried out according to the study protocol, SOPs, & ICH/GCP regulations and study specific manuals and procedures.
� Negotiate and manage the contracts, budgets and payments for third party vendors
� Contribute in other tasks as when assigned by VP/ Function Head
� Hire& retain staffs as per the business need as per management instruction
Key Performance Indicators (Indicate how performance for this role will be measured)
� Compliance with processes and timelines.
� Ensure client satisfaction
Delivery of high quality data according to agreed timelines and budget, ensuring adherence to SOPs, international and local regulations as per business need.
Job Dimensions(Indicate key facts and figures)
Number of associates: May be
Financial responsibility: May be
(Budget, cost, sales, etc.)
Impact on the organization: Internal Impact responsible for the preparation and
review of all documents that are related to clinical
projects, which include contracts, vendor budgets,
and annual reports. In a bid to achieve this, the lead
will have to serve as a middleman between study
sponsors and the clinical research team.
Ideal Background (State the preferred education and experience level)
Education and/or professional experience:
� A Bachelor and/or a Master� degree in any science or health related field.
� A minimum of 5 year� experience in the field of clinical research of which 2 years in a project manager role is preferable
Languages: Fluent in English(oral and written)
Experience / Professional Must possess excellent communication skills so
as to be able to effectively convey messages
across to both study team members and other
external persons like vendors and external
consultants, clients, sponsor.
- Understand clinical study budget.
- Good problem-solving, organizational, and leadership skills are highly required.
- Ability to work with little or no supervision.
- Ability to pay keen attention to detail at all timelines.
- Must be able to work within stipulated time frames or deadlines even in the face of multiple responsibilities or projects.
- Must be able to work as part of a team or in most cases lead a team.
- Ability to organize and motivate other members of the study team Proficient user of basic computer applications for the execution of daily project operations.
- Experience in writing clinical study procedures and other clinical document is a plus.
Other Competencies:(Indicate any other key job requirements necessary for this role)
� Must possess a leadership quality.
� Ethically sound
� Should do work under work pressure.
� Able to communicate with sponsors, vendors efficiently.
� Ability to work on your own initiative and provide accurate summaries.
� Flexibility and adaptability to juggle a range of different tasks and to work extra hours to meet deadlines