Hobson Prior are seeking a Clinical Project Manager for a large Biotech company who specialise in Oncology. This role will be responsible for overseeing and managing the operational activities related to the identification, planning, implementation and reporting of the organisations Investigator Led Studies. The client may be willing to accept a contract agreement for the right candidate.
- Oversee regional planning, management, and reporting of ILS and EAP.
- Recognise opportunities for additional ILS in line with the company’s strategy.
- Support ILS to be conducted in accordance with ICH GxP and relevant national legislation.
- Make sure that necessary technical agreements/contracts with investigators are in place.
- Support the generation of the clinical study protocol.
- Budget tracking of ILS.
- Oversee/facilitate resolution of cross-functional study specific issues related to ILS.
- Develop and maintain global cross-functional business relationships related to ILS.
- Maintain internal and external client/customer satisfaction related to ILS.
- Report progress of ILS at predefined, regular intervals and escalate issues, as appropriate.
- Ensure provision of relevant documentation and appropriate IMP to the investigator.
- You will make sure the investigator is aware of safety reporting requirements.
- Ensure that sponsor investigator receives appropriate safety information and regulatory updates from BGB in a timely manner.
- Proven the ability to manage budgets, project management, process improvement, as well as supervision and performance management.
- Can establish good and productive relationships with cross functional groups.
- Highly organized and able to work self-sufficiently.
- Able to prioritize assignments and deliver according to defined milestones.
- Strong English communication skills (oral and written).
- Able to simplify complex messages and can deliver clear and concise instructions.
- Bachelor’s degree in relevant discipline. Ideally PhD in relevant field.
- In-depth experience in life sciences or medically related field.
- Thorough knowledge of biopharmaceutical clinical research experience obtained at either at a Sponsor Institution, Academic Centre or working on clinical trials at a biotech, pharmaceutical or CRO company.
- Has experience in oversight of outside vendors.
- Experience across therapeutic areas and products.
- Understanding of international regulatory requirements.
- Experience with processes relating to ILS and EAP.
- Experience of clinical operational issues, process and procedures.
- Prior experience writing and presenting clearly on scientific and clinical operational issues.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.