Associate Director, Project Manager Country Operations

AstraZeneca•Mississauga, ON

7d•Hybrid

About The Position

The Associate Director Project Manager Country Operations (AD PMCO) is responsible for the successful execution of study deliverables and the quality execution of high priority and complex protocol procedures within their countries. This role ensures adherence to good clinical practices (GCP), evolving regulatory requirements, and ALXN/AZ working procedures. The AD PMCO leads local study teams, ensuring rapid start-up activities, site identification, feasibility assessments, site qualifications, and timely submission to relevant authorities. They drive adherence to timelines and milestones, manage risks, and prepare mitigation plans. The AD PMCO supports Clinical Research Associates (CRAs) in producing high-quality monitoring throughout the study lifecycle and ensures studies are appropriately resourced. They also oversee recruitment at the country level and liaise with local and global functions to maintain recruitment projections.

Requirements

Bachelor's Degree or equivalent experience in one of the disciplines related to clinical practice/health care, life sciences or drug development is required.
A minimum of 5 years of relevant experience gained with a CRO or pharmaceutical company working on internal delivery model, multinational clinical studies.
Strong project management skills.
Excellent understanding of the end-to-end Clinical Study Process including monitoring.
Comprehensive and current regulatory knowledge, including GCP.
Flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods).
Good organizational skills and ability to deal with opposing priorities.
Effective communication skills (written, verbal, and presentation).
Creative thinker, curious, and unafraid to ask questions.
Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve.

Nice To Haves

A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) is preferred.
Lead/management experience preferred.
Proven experience in managing high priority/complex studies through phases 1 – 4 and in rare medical conditions preferred.
Previous oversight and regulatory inspection experience preferred.
Shown experience in oversight and leading the delivery of operational aspects of all stages of the clinical trial process.
Solid knowledge of clinical development processes, with previous project/site management experience.
Ability to lead, troubleshoot, and influence for quality and delivery.
A track record of ensuring GCP compliance and successful risk management of complex clinical studies is encouraged.
Shown experience in effectively communicating with site staff including KOLs and leaders with a point of view.
Experience conducting GCP or other training is a plus.

Responsibilities

Quality and timeliness of study deliverables: site identification, feasibility, start-up, recruitment, data deliverables, filing of complete study documentation, and site closures for assigned studies.
Conduct country feasibility assessments with the highest quality in collaboration with other functions.
Ensure site selection process is conducted by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits.
Ensure timely submission of application/documents to evaluating authorities at start-up and for the duration of the study.
Collaborate on the negotiation of site study contracts and budgets at the country level.
Ensure all trial essential documents required by ICH-GCP are collected and verified prior to setting sites ready to enroll.
Drive site activation projections for assigned studies.
Set up and maintain the study in CTMS at the country level as well as local registries and websites as required by local laws and regulations.
Oversee, manage, and coordinate monitoring activities from site activation through to study closure.
Meet recruitment targets for assigned studies and drive recruitment projections.
Proactively report study-specific issues to the study team.
Provide functional reporting to HCO and LM including updates on local study team performance and regular information on study milestones/key issues.
Lead risk-based quality meetings and project performance reviews for assigned studies.
Maintain relationships with national coordinating investigators and coordinate country-level engagement activities.
Schedule and lead effective country calls with local study teams and/or CROs.
Lead recruitment discussions with relevant stakeholders for assigned trials and countries.