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AstraZeneca · 1 month ago

Associate Director, Country Operations Management

US - Boston - MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$136K/yr - $205K/yr

8+ years exp

AstraZeneca is a company focused on innovative medicines and ambitious goals. The Associate Director, Country Operations Management will report to the Director, Study Start-Up and Site Partnership, overseeing the delivery of operational trial activities and managing local functional groups to ensure compliance with timelines and quality standards.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

Responsibilities

Leading and developing of the dedicated functional group within Country Operations Management at local level

Ensures adequate resources for the studies assigned, ensure that workload of direct reports is optimized, and ensures appropriate and timely assignment to projects by liaising 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

Manages new staff interviews, hiring, onboarding process, for full-time and and in-sourced staff

Ensures that study activities at country level comply 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). Support the Country external scientific engagement strategy and action plan

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 managing) and onboarding and training of new in-Country COM functions and team members

Act as extended local leadership team member with accountability to support the Country strategy implementation, champion the company values and support HCO with the local affiliate and global DRS team cross-functional interactions required to support local COM goals

Contribute to the quality improvement of the study processes and other procedures through close partnership with DCQ at Country level

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 around those as required (i.e: CAPAs). This may include to conduct Site Oversight Visits triggered by observed quality signals

Plan and conduct regular accompanied/assessment visits with CRAs

Provides support to their CRAs in managing 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, as agreed with their line manager

Collaborates with in-country local roles (PMCO and DCQ) in monitoring quality oversight based on agreed KPIs. Maintain tools to document and track clinical monitoring activities as required

Qualification

Development OperationsLeadershipProject ManagementResource ManagementEnglish ProficiencyAnalytical SkillsTeam BuildingInterpersonal SkillsCommunication SkillsConflict Management

Required

Bachelors degree in related discipline, 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

Strong leadership to drive team growth, development and support the local COM strategy implementation

Pro-active identification of requirements to support future needs

Business acumen to understand company direction and drive the understanding at team level

Solution oriented attitude and ability to lead through ambiguity

Excellent interpersonal skills, proactivity and assertiveness

Manage 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

Preferred

Line management experience and good resource management skills

Prior CRA experience

Excellent 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

Benefits

Qualified retirement programs

Paid time off (i.e., vacation, holiday, and leaves)

Health, dental, and vision coverage

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees