Director, Global Clinical Site Operations

AstraZeneca

Fatih

On-site

TRY 500,000 - 800,000

Full time

14 days+

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Job summary

AstraZeneca in Turkey is seeking a senior Clinical Research Leader to manage country-level oncology studies, oversee the Clinical Research Department, and ensure timely delivery with high quality. You will collaborate with Directors and LSADs to forecast timelines, resources, and study materials while maintaining inspection readiness of eTMF.

The role requires extensive CRO/LSAD coordination, strong leadership, and a proven track record in project management, stakeholder engagement, and

Qualifications

University degree in healthcare related areas.
Advanced level of English.
Minimum 5 years of experience in clinical research field preferably in oncology (CRA / Sr. CRA / LSAD/ADCR/LM) or other related fields if experience is adequate.
Minimum 2 years experience for Local Study Manager position in Oncology area, preferably
Line Management experience, preferably
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
Driving License
No military obligation for male candidates.

Responsibilities

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/organizes coaching with external providers if needed.
Contributes to efficient Clinical Research Department organization and its functioning at country level by working closely with responsible Director, Oncology Country Head, Clinical Research Department.
Contributes to high quality feasibility work.
Oversees successful delivery of Clinical Research 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 Director, Oncology Country Head, Clinical Research Department or Local Study Associate Directors /CRAs/teams in forecasting study timelines, resources, recruitment, study materials and drugs.
Provides direction to LSADs/teams on major study commitments including resolving any key issues identified.
Supports Clinical Research Department region in initiatives/activities as agreed with Director, Oncology Country Head, Clinical Research Department.
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/co-monitoring visits/training visits/QC visits according to local QC Plan, supporting ongoing coaching and development.