Associate Director, Clinical Research

工作内容

The Associate Director Clinical Research (ADCR) is responsible for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

The ADCR is responsible for line managing dedicated group(s) of staff such as Clinical Research Associates (CRAs) and/or Clinical Study Administrators (CSAs) and is responsible for planning and utilization of staff resources, objective setting and performance follow-up.

As assigned, the ADCR is responsible for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived, as agreed locally.

In some countries a ADCR may also take responsibilities as Local Study Associate Director (LSAD) if required and agreed with the (Senior) Director, Country Head.

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 (Senior) Director, Country Head and local HRBP.
• Contributes to efficient SMM organisation and its functioning at country level by working closely with responsible (Senior) Director, Country Head.
• Contributes to high quality feasibility work.
• Supports 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”.
• Provides direction to CRAs and CSAs on major study commitments including resolving any key issues identified.
• Ensures that study activities at country level comply with local policies and code of ethics.
• Reviews monitoring visit 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. Ongoing communication with Functional Service Providers, including directions and feedback on insourced/outsourced work
• If ADCR takes a role as LSAD, please refer to the corresponding Job description.
  
  

Qualifications

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Minimum 4 years of experience in Development Operations (CRA / SrCRA / LSAD) or other related fields.
• Excellent interpersonal skills.
• Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
• Project management experience.
• Excellent organisational, analytical, influencing and negotiation skills.
• Excellent presentation and communication skills, verbal and written.
• Excellent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT systems.
• Ability for national travel, if applicable.