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AstraZeneca

Associate Director, Project Manager Country Operations

Discovered
AstraZeneca
US - Boston - MAFull timePosted 9 days ago (Aug 4, 2026)

About the role

The AD Project Manager Country Operations (AD PMCO) is accountable within their   countr ies   for the successful execution of study   deliverables   and the quality execution of high priority and / or complex protocol procedures through adherence to good clinical practices (GCP), evolving regulatory requirements, ALXN/AZ working procedures with the agreed resources and ensuring quality and consistency in timely completion of   site management and   monitoring activities.   The AD PMCO is accountable for   leading local study teams,   ensuring rapid   start up activities across assigned   studies , ensuring that sites are identified, feasibility is conducted, site qualifications performed, the study is submitted to the relevant authorities for evaluation, sites are set up, monitored, closed and final documentation   archived .   The AD PMCO will also drive adherence to timelines and milestones of study goals as well as   identifying ,   managing   and communicating risks to the study team and preparing mitigation plans.    The AD PMCO will ensure that monitoring activities at study sites results in the effective identification and problem solving of issues. AD PMCO will support CRAs in producing high quality of monitoring throughout the cycle life of the study. For that purpose ,   the AD PMCO will ensure that CRAs assigned to the study understand complex protocol processes and procedures and may support CRA protocol-specific training. AD PMCO will also   identify   any resourcing issue and discuss with the relevant stakeholders ( i.e :   relevant people manager ) to ensure that assigned studies are appropriately resourced.    The AD PMCO will be accountable for ensuring study design and timelines are achievable in the local environment and meeting performance expectations .     The AD PMCO, in coordination with other stakeholders ( e.g : Quality Representative, Head of Country Operations,   People   Manager, etc), and as part of the exercise of   country risk assessment, will identify the need to conduct oversight site visits / accompanied site visits. Those might be conducted by the AD PMCO or other functions   accordingly with the ASV guidance   and under to accountability of HCO .     The AD PMCO will remain accountable for the delivery of the recruitment at country level. The AD PMCO will   liase   with local   affiliate   and global functions to   implement the most effective Country and Site recruitment action plan to deliver the committed recruitment   with quality .

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   sites   closures for assigned study( ies ). T his includes:    • CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party).   • Conduct of country feasibility assessment of potential studies with the highest quality, in collaboration with   local affiliate functions and other global stakeholders .    • Ensuring site selection process is conducted by   identifying   potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.   • Ensuring   timely   submission of application/documents to evaluating authorities ( i.e : EC/IRB and Competent Authorities as applicable) at start up and for the duration of the study, in line with local regulations. This will include the coordination   and collaboration , with the start up positions (where available) of the preparation of the country level Master Informed Consent Form (MICF) and   subsequent   site level ICFs, as   required , including any relevant translation, in line with relevant SOPs. country/site level for the assigned studies.   • Collaboration   for   the negotiation of site study contracts and budgets for the assigned studies at country level in coordination with other functions such as   start up   manager. The AD PMCO will ensure   timely   preparation of local Master CSA (including site budget) and amendments as applicable in the country.   • Ensuring that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to   enroll , and in line with applicable SOPs.   • Driving the   compliance with the committed   site activation projections for the assigned studies   • Set up and maintenance of the study in CTMS   at study   country level as well as local registries and websites as required by local laws and regulations.   • Oversight, management and coordination of monitoring activities from site activation through to study closure at country and site level   in accordance with   the Monitoring Plans.   • Meeting recruitment targets for assigned study( ies ) and driving the   Country/site recruitment action plan   to deliver th e   recruitment projections for the assigned studies.   • Proactive reporting of study-specific issues (including monitoring metrics) to the study tea m.   • Functional reporting to HCO   and   LM   including:    • Updates about the performance of   local   study team (CRAs, CSA, etc.)   • Regular information at country level on study/ ies   and planned study milestones/key   risks and   issues.    • Leading risk-based quality meetings, project performance reviews,   etc   for the assigned studies.    • Regular information on any research related information including sites/investigators/competing studies that might be useful for the local market.   • Report regular updates on assigned projects progresses, risks, action plans   • Pro-actively   identify   potential risks at Country   level and   timely   escalate   and provide risk mitigation   plan   to HCO .   • Supporting HCO to drive the Country strategy to achieve Country goals . Proactively   identify   and lead   actions and projects to implement at Country level, aligned with Country goals and strategy defined by HCO, to support the grow th   and performance process improvement.   • Relationship management with the national   key opinion leaders , involved in the relationship management with key Patient Advocacy Organization and other external stakeholders which can have impact on the Country rare disease strategy in clinical development .   A ccountable for the Country external scientific engagement plan for the assigned study and/or therapeutic area .   Supporting other Country team   member   with the implementation of the   activities associated   to   the external scientific engagement plan.   • Potential to act as   m entor of Senio r   Manager PMCO   and Country Study Manager.

You will need to have

• Strong leadership:   including the ability to make decisions independently,   ability   to combine   role   of formal, informal lead e r,   mentor   and coach.   Independently   determines   the goals for the local study team, prioritize them , implement   the   strategic line of development of the entrusted directions.   Ability to lead,   troubleshoot   and   influence   quality and delivery.   • Strong communication skills:   have strong social skills to build powerful and   trustful   relationships   with internal and external stakeholders.   To be recognized as   a reliable   source of support and guidance by the   g lobal   s tudy   t eam,   managers   and colleagues.   Good independent management of tense and   difficult   situations   supporting the team to keep focus on the goals,   objective   and company values.   Proven experience in effectively communicating with site staff including KOLs and thought leaders.   Effective communication skills (written,   verbal   and presentation). Good intercultural awareness.     • Excellent organizational skills and planning:   independently plan and manage projects of any complexity, including managing the budget of projects.   Ability to work effectively cross-functionally.   Independently   and   timely   risks   identification and development of mitigation and action plan . Proven 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.   A track record   of ensuring GCP compliance and successful risk management of complex clinical studies is expected. Comprehensive and current regulatory knowledge, including GCP. Experience conducting GCP or other training is a plus. Good organizational skills and ability to deal with competing priorities.   • Champion of the company values.   • Flexibility in schedule and willingness to travel ( required   travel may be as high as 20% during busy periods).   • Proficient with MS Office Suite (Excel,   Word   and PowerPoint).    • Excellent knowledge of spoken and written English.

Minimum Qualifications

• Bachelor's Degree or equivalent 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 CRA/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.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you! The annual base pay for this position ranges from $ 142,171.20 - 213,256.80 USD Annual . Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

04-Aug-2026

Closing Date

19-Aug-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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This role was discovered from a public careers page. Applications are handled by the hiring team at AstraZeneca.

Attribution: sourced from AstraZeneca's public Workday board.

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