Associate Director, Project Manager Country Operations

Introduction to role

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.

Accountabilities

• 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.

Essential Skills/Experience

• Bachelors Degree or equivalent experience in one of the disciplines related to clinical practice/health care life sciences or drug development is required. A clinical or advanced degree (RN MPH MS MA MBA PharmD) is preferred.

• A minimum of 5 years of relevant experience gained with a CRO or pharmaceutical company working on internal delivery model multinational clinical studies; Lead/management experience preferred.

• Strong project management skills.

• 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.

• Excellent understanding of the end-to-end Clinical Study Process including monitoring.

Desirable Skills/Experience

• 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.

• Comprehensive and current regulatory knowledge including GCP.

• Experience conducting GCP or other training is a plus.

• 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.

Alexion Canada

Since beginning our operations in Canada in 2009 Alexion has been working tirelessly to bring innovative medicines to the millions of Canadians living with rare diseases. Our pioneering 30-year legacy our scientific expertise and our commitment to patient-centric decision-making are the foundations of what we are today a company with a mission to transform lives.

Our Canadian team

We know that people living with a rare disease and their families deserve our unwavering commitment and investment into finding and accessing therapies that help them live longer fuller lives. Our presence in Canada has grown to over 200 employees and includes a global research and development hub made up of highly skilled professionals responsible for conducting our clinical trials in Canada and around the world as well as our dedicated and passionate local teams that ensures our treatments reach those who need them. Together we are driving patient impact locally and globally.

How we work
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Alexion 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. Alexion is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment assessment and selection process and may be requested by emailing .

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors including the candidates skills and experience job-related knowledge and other specific business and organizational some cases offers outside the range may also be considered to address unique circumstances.

In addition our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program 4 weeks paid vacation and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.