Associate Director of Clinical Operation in Poland
4 days left
- Experience Level
At AstraZeneca we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we're on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you're swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
The Associate Director of Clinical Operation in Poland is accountable locally for delivering the committed part of all clinical interventional studies under their supervision 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 Associate Director of Clinical Operation in Poland is responsible for line managing dedicated group(s) of staff and responsible for planning and utilization of staff resources, assigned budget, objective setting and performance follow-up. It is also expected that the Associate Director of Clinical Operation in Poland may contribute to regional/global work tasks as delegated. As assigned, the Associate Director of Clinical Operation in Poland is accountable for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
- Leadership of dedicated group, building the team spirit, developing team style and behaviour, coaching
- Ensures adequate resources for the studies assigned and that the workload of direct reports is adequate.
- Development and performance management of direct reports; prepares salary and bonus proposals
- Contributes to high quality feasibility work - oversees successful delivery of study delivery country level targets to plan
- Ensures all systems are continuously updated - ensures completeness and timeliness of the eTMF to maintain it "Inspection Ready".
- Assists Clinical Director or Local Study Managers/teams in forecasting allocated studies; provides direction on major study commitments, reviews SQV reports
- Minimum 2 years of experience in line management and proven project management experience; excellent team building skills also in cross-functional teams.
- Minimum 5 years of experience in Development Operations (CRA / Sr. CRA / LSM) or other related fields - excellent understanding of the Study Drug Handling Process and the Data Management Process.
- Bachelors degree in related discipline, preferably in life science, or equivalent qualification - good medical knowledge and ability to learn.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time, good ability to learn and to adapt to work with IT systems.
- Ability to work in an environment of remote collaborators, good intercultural awareness - excellent interpersonal and operational skills
- Excellent presentation and communication skills, verbal and written - very good knowledge of spoken and written English