The Clinical Research Manager (CRM) is accountable 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 CRM 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 CRM may contribute to regional/global work tasks as delegated.

As assigned, the CRM is accountable for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Typical Accountabilities

• Leadership of dedicated group, building the team spirit, developing team style and behaviour.
• Ensures adequate resources for the studies assigned.
• Ensures that the workload of direct reports is adequate.
• 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.
• Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible CH/CD SMM and local HRBP.
• 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.

Date Posted

25-thg 9-2019

Closing Date

29-thg 11-2019

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 authorization and employment eligibility verification requirements.