The Clinical Trials Project Management executive is responsible for all activities including sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, SOPs, GCP and/or other guidelines to be compliant with the local regulations, production of key project progress reports, management of communication between project team, sponsor, contract and financial management. In addition, he/she manages the teams responsible for site monitoring involving site-start-up, execution, and close-out. He/She reports to Leadership-Clinical Trials. He/she provides supervision of assigned Clinical Research Associates (CRAs) and help develop/manage their projects. Manage the resources both internal and external including clients, third party contractors, and vendors.
- Serve as a primary liaison between project Sponsor and JSTL to develop Master Service Agreement (MSA).
- Provide guidance on MSA to all affected Functional Leads (FL) at JSTL.
- Develop Standard Operating Procedure (SOP) for the management of clinical trials including purpose, intent, definitions, roles and responsibilities.
- Manage the project initiation with the involvement of all parties including, Sponsor, FLs, Investigational site (IS) monitors, and Investigators and their staff.
- Provide supervision to CRAs in IS evaluation/selection, contracts, budget negotiations, legal/ethical requirements, and regulatory requirements.
- Ensure adherence to National and local regulations, Good Clinical Practices (GCP) and ICH guidelines, and JSTL SOPs.
- Stay abreast of any new changes in the above guidelines and governmental reforms within the country that affect the conduct of Clinical Trials.
- Ensure audit and inspection readiness of assigned sites, prepare and follow-up site audit systems are compliant.
- Accountable for full implementation of assigned projects and within budgets by appropriate resource management.
- Provide periodic assessments as per SOP to the Sponsor and JSTL leadership. Assessments include but not limited to personnel, budget allocations, key issues, and solutions.
- Responsible for maintaining MSAs in Microsoft Management Tool and draw metrics as appropriate for both internal and external utilization.
- Responsible for hiring and retaining the top talent required in the conduct of Clinical Trials and ensure their training and performance management.
Qualification, Experience, and Skills Required:
Education and Experience:
- A minimum of a Master of Science in life sciences with significant relevant project management experience.
- A relevant advanced degree (e.g. MS Pharmacy, PharmD, PhD, MD) is preferred, and higher education may compensate for years of experience.
- A certificate in Clinical Trial Project Management is highly preferred.
- Minimum of 3-5 years of relevant industry experience in the project management of Clinical Trials in any healthcare industry or pharmaceutical industry.
- Experience in Clinical Trial (Phase I-IV) operations is preferred.
- Excellent interpersonal relationship building communications both in writing and verbal is essential.
- Proficient in English along with local languages to communicate with internal and external staff.
- Must have strong planning and organizational skills with flexibility to work in dynamic environment of projects in different therapeutic areas.
- Drive innovative approaches in developing improvement to the procedures and processes challenging status quo.
- Highly enthusiastic and a team player with ability to do multitasking, excellence in diverse teams, and with ethics and integrity.
- Must be able to work independently and complete the tasks on time keeping in mind that the tasks are highly regulated with patient focus.
- Strong analytical and critical thinking skills to evaluate complex issues and drive smart decision making that satisfies both the Sponsor and JSTL with greater impact on successful completion of assigned projects.
- Must have excellent working knowledge of Microsoft Project Manager and other IT applications necessary for the management, maintenance and creation of necessary metrics.