Associate Director, Site Management and Monitoring (SM&M)

Job Description

The Associate Director Site Management and Monitoring (ADSM&M) 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 ADSMM 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 ADSMM may contribute to regional/global work tasks as delegated.

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

In some countries an ADSMM may also take responsibilities as Local Study Manager (LSM) or Clinical Quality Manager (CQM) if required and agreed with the CH/CD.

Typical Accountabilities

Leadership of dedicated group, building the team spirit, developing team style and behavior.

Ensures adequate resources for the studies assigned and that the workload of direct reports is adequate.

Development and performance management of direct reports and 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.

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 organization and its functioning at country level by working closely with responsible CH/CD SMM and contributes to high quality feasibility work.

Oversees successful delivery of SMM study delivery country level targets to plan, with speed and quality and contributes to the quality improvement of the study processes and other procedures and 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 and supports SMM region in initiatives/activities as agreed with CH/CD SMM.

Ensures collaboration with local Medical Affairs team and 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. This is a global role in scope.

Education, Qualifications, Skills and Experience

Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification .

Minimum 5 years of experience in Development Operations (CRA / Sr. CRA / LSM) or other related fields. Oncology T.A. and experience managing Project Managers highly desired in pharma/biotech.

Excellent interpersonal skills. Manage change with a positive approach for self, team and business.

Line management experience and very good knowledge of the Clinical Study Process and international ICH-GCP guidelines.  Excellent knowledge of the Monitoring Process.

Good understanding of the Study Drug Handling Process and the Data Management Process and good knowledge of relevant local and international regulations. Good medical knowledge and ability to learn.

Proven project management experience with excellent organizational, analytical, influencing and negotiation skills. Excellent presentation and communication skills, verbal and written. Ability for national and international travel when feasible.

Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. Integrity and high ethical standards, good resource management skills, excellent decision-making skills, good financial management skills, and good conflict management skills and ability to handle crisis.

Good interviewing skills – responsibility for attracting, developing and retaining personnel. Excellent team building skills also in cross functional teams, strong intercultural awareness. Ability to work according to global standards.