Job Description
The Director, Study Start Up, Site Management & Monitoring (DSMM SSU) is accountable for collectively delivering the UK commitments for BioPharma clinical interventional studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. The current vacancy will be responsible for SSU across all therapy area (TA) portfolio studies including specialty indications through establishing key relationships with partner organisations and KEEs. The DSMM SSU is accountable for ensuring that study sites are identified, site qualifications performed and set up through to site initiation /activation with close oversight and improvement of SSU KPIs expected. The DSMM SSU works closely with the TA DSMMs to strategically plan across TA portfolios ensuring optimal study placement and delivery. The DSMM SSU is responsible for line managing a dedicated team of staff responsible for SSU activities, including planning and utilization of SSU team resources, managing assigned resource budget, team objective setting and performance development. Experience in SSU within UK trials environment including collaboration with clinical trial networks is an advantage.
Responsibilities + Skills
Excellent organisational, analytical, influencing and negotiation skillsExcellent presentation and communication skills, verbal and writtenExcellent knowledge of spoken and written English
Education
Bachelor degree in related discipline, preferably in life science, or equivalent qualificationRelevant years of experience in Development Operations (CRA / SrCRA / Project Manager) or other related fields
Experience