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Associate Director, Country Operations Management

2 months ago

Mississauga Ontario CW, Peel region, Canada AstraZeneca GmbH Full time

This is what you will do:

The Associate Director Country Operations Management (AD COM) is responsible for day-to-day management of a dedicated functional group(s) within Country Operations, and is responsible for planning and utilization of staff resources, objective setting and performance development. The AD COM is responsible for their direct reports delivery to study expectations.

It is also expected that the AD COM may contribute to regional/global initiatives as delegated.

In some countries AD COM may also take other responsibilities such as Project Manager Country Operations (PMCO) if required, as agreed with the Head of Country Operations (HCO).

You will be responsible for:

  • Leadership of dedicated functional group within Country Operations.
  • Ensures adequate resources for the studies assigned, ensure that workload of direct reports is optimized, and ensures appropriate and timely assignment to projects by collaborating closely with relevant stakeholders (HCO, PMCO, global study team, etc).
  • Development and performance management of direct reports, including implementation of development and training plan and regular coaching of the direct reports.
  • Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible HCO.
  • Leads new staff interviews, hiring, onboarding process, for full-time and in-sourced staff.
  • Ensures that study activities at country level align with local policies and code of ethics, and ensures team delivery to committed activation and recruitment targets.
  • Contribute to Country feasibility analysis for new potential clinical trials (as applicable, depending on the direct reports the LM will be managing).
  • Contribute to efficient COM organization and its functioning at country level by working closely with responsible HCO.
  • Support HCO and in-Country COM activities as agreed with HCO, such as Site Oversight Visit reports review (as applicable, depending on the direct reports the LM will be handling) and onboarding and training of new in-Country COM functions and team members.
  • Contribute to the quality improvement of the study processes and other procedures.
  • Support inspection readiness activities at site and country level.
  • Collaborates in identifying patient, site or country level quality deficiencies which may lead to the creation quality events/issues, and support in discussions about those as required (i.e: CAPAs). This may include to conduct Site Oversight Visits triggered by observed quality signals.
  • Ensure collaboration with local Medical Affairs team, Medical Advisor Pipeline, and other relevant stakeholders.

For individuals managing CRAs to:

  • Plan and conduct regular accompanied/assessment visits with CRAs.
  • Provides support to their CRAs in handling site issues, from a monitoring perspective, ensuring that monitoring activities are conducted according to expectations.
  • May act as a site liaison with prime sites for Alexion to facilitate discussion and consultation around site compliance to ICH GCP and process improvements.
  • Collaborates with in-country local roles (PMCO) in monitoring quality oversight based on agreed KPIs. Maintain tools to document and track clinical monitoring activities as required.

You will need to have:

  • Bachelors degree in related field, preferably in life science, or equivalent qualification.
  • Minimum 8 / 5 (for LM of CRAs only) years of experience in Development Operations (CRA / Sr. CRA / Project management) or other related fields.
  • Excellent communication skills, proactivity and assertiveness.
  • Handle change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
  • Excellent organizational, analytical, influencing and negotiation skills.
  • Excellent presentation and communication skills, verbal and written.
  • Excellent knowledge of spoken and written English.
  • Ability for national and international travel.
  • Integrity and high ethical standards.

We would prefer for you to have:

  • Line management experience and good resource management skills.
  • Demonstrated knowledge of the Monitoring Process.
  • Good understanding of the Study Drug Handling Process and the Data Management Process.
  • Ability to work in an environment of remote collaborators.
  • Excellent decision-making skills.
  • Good conflict management skills and ability to handle crisis.
  • Excellent team building skills also in cross-functional teams.
  • Good intercultural awareness.
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