Senior Clinical Project Manager
This individual will be responsible for the planning and executing of trials for the Clinical Operations function. He/she will work closely with multi-disciplinary departments and will require a solid understanding of the clinical trial lifecycle management such as study startup, feasibility, patient recruitment, project management, site management and site quality oversight. He/she will also be overseeing CROs and other related third-party vendors which are delegated to execute studies on Tessa's behalf.
Responsibilities
- Ensure that global clinical strategies are translated to study specific strategies.
- Ensure that the trials are run in adherence to all relevant regulations including GCP, ICH, local regulatory requirements, as well as SOPs and policies.
- Provide operational input into study designs, protocols and study plans to ensure that they are operationally feasible at the country, site, and patient levels
- Oversees the execution and adherence to all integrated study operation plans, with inputs from key stakeholders.
- Oversee the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with CRO Management and key stake holders
- Work closely with the CRO to manage China sites and have face to face meetings with Chinese doctors.
- Set Key Performance Indicators (KPIs) and roll out metrics to track the quality and performance of the studies.
- Monitor study progress, study budget, study timeline
- Identify quality and deliverable risks, roll mitigation plans together with the relevant stakeholders, to ensure risks are minimized.
- Establish good working relationships with the key participating sites and be the point of sponsor contact escalated site issues.
- Conduct regular onsite monitor assessment visits.
- Provide inputs into site audit report responses and responsible for oversight of associated plans
Requirements
- Bachelor's Degree in a field of Biomedical science, pharmacy, nursing, or medical related courses with at least 10 years' experience working in clinical research and at least 4 years of clinical project management experience in oncology studies.
- In depth knowledge of oncology trials requirements, clinical research principles such as ICH GCP as well as regulatory requirements.
- Strong communication and influencing skills
- Strong organizational and problem-solving skills
- Strong supervision and oversight skills
- Effective presentation skills
- Strong ability to deliver results to the appropriate quality and timeline metrics
- Good judgment
- Ability to manage competing priorities
- Experiences in immuno-oncology and/or gene and cell therapy studies are advantages.
- Proficiency in MS Excel required, programming knowledge an advantage
Please send your resume in WORD format by clicking the apply button below or contact Jochen Surrey on +65 6701 1516 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878834 (Jochen Nico Surrey).
