About the Role:
Jim Gleeson is recruiting for a Senior Manager, Study Management to join a leading Biotechnology company. This role will be preferably based in the Middlesex area however there may be flexibility on this role to be based in the Cambridgeshire area, on a full time, permanent basis.
This role sits with in a Global Operations teams and involves overseeing and managing operational activities related to the planning, implementation, and reporting of non company sponsored trials. An area of the company which is dedicated to developing the gap in scientific and clinical research in relation to company products which may be able to be used in other indications.
You will also oversee the support of Investigator Sponsored Studies (ISS), other non company sponsored studies, and Expanded Access (EA), ensuring global standardization, according to applicable SOPs and plans.
As a Senior Manager, you will have the following responsibilities and activities:
- Oversee regional planning, management, and reporting of studies including ISS, Co-operative group ISS, Research Partner Studies and EA.
- Oversee regional cross-functional activities, identifying and resolving issues for global standardisation.
- Partner with the Director and counterpart Sr. Manager to ensure global alignment and standardisation in process.
- Act as regional subject matter expert in global process standardisation and process improvement initiatives.
- Oversee/facilitate resolution of cross-functional study specific issues.
- Establish and maintain global cross-functional business relationships.
- Establish and maintain internal and external client/customer satisfaction.
- Ensure regional support in accordance with global ISS SOP, EA MAN and other supporting documentation.
- Oversee or input into regional resourcing to meet demand.
- Manage and/or mentor regional and local staff, as applicable.
- Escalate issues, as appropriate, to Director and either lead or support resolution.
- Collaborate within global group, and within cross functional matrix.
As a Senior Manager you will have the following qualifications, skills and experience:
- Minimum Bachelor's degree in relevant discipline, or RN
- Broad experience in life sciences or medically related field, including general knowledge of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical company or CRO)
- In-depth experience in life sciences or medically related field, including thorough knowledge of biopharmaceutical clinical research experience obtained either at a Sponsor Institution, Academic Centre or working on clinical trials at a biotech, pharmaceutical or CRO company.
- Previous management experience of direct reports.
- Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, etc.).
- Experience across therapeutic areas and products.
- Knowledge of international regulatory requirements.
- Experience with processes relating to externally sponsored studies (Investigator Initiated Studies) and Expanded Access.
- Experience of clinical operational issues, process and procedures.
- Experience collaborating & leading cross functional teams (team matrix environment).
- Experience working internationally/globally.
For more information or to apply for this Senior Manager, Study Management position please contact Jim Gleeson on [... Click Apply...]973 or email [... Click Apply...].