Director, Site Management and Monitoring (SMM) Hematology

AstraZeneca•Wilmington, DE

19d•Remote

About The Position

The Director, Site Management & Monitoring (DSMM) delivers the committed part of all clinical interventional studies under their management. This delivery must accord to agreed resources, budget, and timelines, and must comply with AZ Procedural Documents, international guidelines such as ICHGCP, and local regulations. The DSMM is responsible for line managing dedicated group(s) of staff and responsible for planning and use of staff resources, assigned budget, objective setting and performance follow-up. The DSMM is also expected to contribute to regional and or global tasks and initiatives as delegated. As assigned, the DSMM ensures that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. In some countries a DSMM may also take responsibilities as Local Study Associate Director (LSAD) or Clinical Quality Associate Director (CQAD) if required and agreed with the (Senior) Director, Country Head. You Will: Support SMM region in programs/activities as agreed with (Senior) Director, Country Head. Ensure collaboration with local Medical Affairs team. Ensure that study activities at country level comply with local policies and code of ethics. Review SQV reports of direct reports following AZ SOPs Review accompanied site visits/co- monitoring visits/training visits/QC visits performed to direct reports following the local QC plans. Perform accompanied site visits according to local QC Plan, supporting ongoing coaching. Lead dedicated group, building the team spirit, developing team style and behavior. Ensure resources for the studies assigned. Ensure that the workload of direct reports is adequate. Development and performance management of direct reports. Ensure that direct reports have development plans, according to IDP process. Coach the direct reports, and plans/organise coaching with external providers. Prepare salary and bonus proposals for direct reports based on their performance in close collaboration with responsible (Senior) Director, Country Head and local HRBP. Contribute to efficient SMM organization and its functioning at country level by working with responsible (Senior) Director, Country Head. Contribute to high-quality feasibility work. Oversee delivery of SMM study delivery country level targets to plan, with speed and quality. Contribute to the quality improvement of the study processes and other procedures. Ensure all systems are updated. Ensure completeness and timeliness of the eTMF to maintain it “Inspection Ready”. Assist (Senior) Director, Country Head or Local Study ADs/ Local Study Teams in forecasting study timelines, resources, recruitment, study materials and drugs. Direct LSAD/ Local Study Teams on major study commitments including resolving any

Requirements

Bachelor's degree in related discipline in life science, or equivalent qualification.
Minimum seven (7) years of experience in Development Operations (CRA / SrCRA / LSAD) or other related fields.
Project management experience
Excellent knowledge of spoken and written English.
Adept to working with IT systems.
Ability for national and international travel.

Nice To Haves

Knowledge of the Clinical Study Process,Monitoring Process and international ICH-GCP guidelines.
Demonstrated experience with conflict management.
Experience with the Study Drug Handling Process and the Data Management Process.
Knowledge of relevant local and international regulations.
Look for and promote more efficient methods/processes of delivering quality clinical trials with reduced budget and in less time.
Background in Hematology therapeutic area.
Work in an environment of remote collaborators.
Good resource management and financial management skills.

Responsibilities

Support SMM region in programs/activities as agreed with (Senior) Director, Country Head.
Ensure collaboration with local Medical Affairs team.
Ensure that study activities at country level comply with local policies and code of ethics.
Review SQV reports of direct reports following AZ SOPs
Review accompanied site visits/co- monitoring visits/training visits/QC visits performed to direct reports following the local QC plans.
Perform accompanied site visits according to local QC Plan, supporting ongoing coaching.
Lead dedicated group, building the team spirit, developing team style and behavior.
Ensure resources for the studies assigned.
Ensure that the workload of direct reports is adequate.
Development and performance management of direct reports.
Ensure that direct reports have development plans, according to IDP process.
Coach the direct reports, and plans/organise coaching with external providers.
Prepare salary and bonus proposals for direct reports based on their performance in close collaboration with responsible (Senior) Director, Country Head and local HRBP.
Contribute to efficient SMM organization and its functioning at country level by working with responsible (Senior) Director, Country Head.
Contribute to high-quality feasibility work.
Oversee delivery of SMM study delivery country level targets to plan, with speed and quality.
Contribute to the quality improvement of the study processes and other procedures.
Ensure all systems are updated.
Ensure completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
Assist (Senior) Director, Country Head or Local Study ADs/ Local Study Teams in forecasting study timelines, resources, recruitment, study materials and drugs.
Direct LSAD/ Local Study Teams on major study commitments including resolving any

Benefits

A qualified retirement program [401(k) plan]
Paid vacation, holidays, and paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans.
Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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