Leading the local study teams (consisting of monitors and study administrators) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines
Ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived
Ensuring timely submissions of proper application/documents to Ethic Committee/Regulatory Authority
Close communication with global study teams and overall responsibility for study commitments, for timely delivery of data to required quality as agreed with global
Creating and implementing alternative action plans proactively in order to reach the targeted patient numbers; monitoring the patience admission processes in coordination with the researchers; planning and taking the necessary precaution when required
Ensuring the compliance of the clinical research process with ICH-GCP practices, the study protocol, AZ Global and Local Clinical SOP’s, and the Ministry of Health Clinical Research Regulations; being knowledgeable about these procedures and keeping abreast of any changes and revision
Participating in system/process improvement projects within global and local task groups consisting of employees from different units

University degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties)
Advanced level of English
Minimum 5 year experiences in Clinical Research (preferably 2 years in Project Management positions and Oncology specific)
Project management skills
Strong communication and negotiation skills
Ability to prioritize and handle multiple tasks
Basic coaching skills and good at team work
Financial management skills
Effective planning and organizational skills with result-oriented approach
Stakeholder management experience
Analytical thinking, critical reasoning ability
Good command of MS Office applications
No restriction to travel
Driving License
No military obligation for male candidates.

Local Study Associate Director – Biopharma

Key skills