Background & Qualifications
University degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties),
Advanced level of English,
Minimum 5 years of experience in Development Operations (CRA / Sr. CRA / LSM) or other related fields.
Minimum 2 years experience for Local Study Manager position
Proven project management experience.
Excellent presentation and communication skills, verbal and written.
Excellent organisational, analytical, influencing 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,
No military obligation for male candidates.
Summary Job Description
Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
Ensures adequate resources for the studies assigned.
Development and performance management of direct reports.
Ensures that direct reports have development and training plans, according to IDP process.
Coaches the direct reports on a regular basis, and plans / organises coaching with external providers if needed.
Contributes to efficient SMM organisation and its functioning at country level by working closely with responsible CH / CD SMM.
Contributes to high quality feasibility work.
Oversees successful delivery of SMM study delivery country level targets to plan, with speed and quality.
Contributes to the quality improvement of the study processes and other procedures.
Ensures all systems are continuously updated.
Ensures completeness and timeliness of the eTMF to maintain it Inspection Ready .
Assists CH / CD SMM or Local Study Managers / teams in forecasting study timelines, resources, recruitment, study materials and drugs.
Provides direction to LSM / teams on major study commitments including resolving any key issues identified.
Supports SMM region in initiatives / activities as agreed with CH / CD SMM.
Ensures collaboration with local Medical Affairs team.
Ensures that study activities at country level comply with local policies and code of ethics.
Reviews SQV reports of direct reports in line with AZ SOPs
Reviews Accompanied site visits / co- monitoring visits / training visits / QC visits performed to direct reports in line with the local QC plans.
Performs accompanied site visits according to local QC Plan, supporting ongoing coaching and development.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.