Associate Director, Project Manager Country Operations

As an Associate Director, Project Manager Country Operations (AD PMCO), you will be accountable for the successful execution of study deliverables and the quality execution of high-priority and complex protocol procedures within your assigned countries. You will ensure adherence to good clinical practices (GCP), evolving regulatory requirements, and company working procedures. Your role involves leading local study teams, ensuring rapid start-up activities, identifying and qualifying sites, submitting studies to relevant authorities, and overseeing site management and monitoring activities. You will drive adherence to timelines and milestones, manage risks, and support Clinical Research Associates (CRAs) in producing high-quality monitoring throughout the study lifecycle.

You will be responsible for:

- 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.
- Conducting country feasibility assessments of potential studies with the highest quality.
- Ensuring site selection processes are conducted by identifying potential sites/investigators, performing initial Site Quality Risk Assessments, and conducting Site Qualification Visits.
- Ensuring timely submission of application/documents to evaluating authorities at start-up and for the duration of the study.
- Collaborating on the negotiation of site study contracts and budgets at the country level.
- Ensuring all trial essential documents required by ICH-GCP are collected and verified prior to setting sites ready to enroll.
- Driving site activation projections for assigned studies.
- Setting up and maintaining the study in CTMS at the country level as well as local registries and websites as required by local laws and regulations.
- Managing and coordinating monitoring activities from site activation through to study closure.
- Meeting recruitment targets for assigned studies and driving recruitment projections.
- Proactively reporting study-specific issues to the study team.
- Leading risk-based quality meetings, project performance reviews, and providing regular updates on study milestones/key issues.
- Managing relationships with national coordinating investigators and coordinating country-level engagement activities.
- Leading recruitment discussions with relevant stakeholders for assigned trials and countries.

Essential Skills/Experience:

- Bachelors degree in related field, preferably in life science, or equivalent qualification.
- 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.

Desirable Skills/Experience:

- 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 crises.
- Excellent team-building skills also in cross-functional teams.
- Good intercultural awareness.

At AstraZeneca, we are committed to making a difference by fusing data and technology with the latest scientific innovations. We are driven by curiosity and courage, inspired by the possibility of doing things that have never been done before. Our inclusive environment allows us to work seamlessly as one team, leveraging our diverse global knowledge to create the greatest impact on disease. We offer varied opportunities for lifelong learning and career development as we push the boundaries of science to deliver life-changing medicines.

Join us in our mission to follow the science and explore new frontiers. Apply today!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.