Associate Director, Project Manager Country Operations

Accountable within assigned countries 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, and ALXN/AZ working procedures. Ensures quality and consistency in timely completion of site management and monitoring activities with agreed resources.

Responsibilities

• Lead local study teams, ensuring rapid start-up activities across assigned studies, including site identification, feasibility, qualification, regulatory submissions, site setup, monitoring, closure, and final documentation archiving.
• Drive adherence to timelines and milestones, identify and manage risks, and prepare mitigation plans for study goals.
• Ensure monitoring activities effectively identify and resolve issues at study sites, supporting CRAs in producing high-quality monitoring throughout the study lifecycle.
• Ensure CRAs understand complex protocol processes and procedures; may support protocol-specific training.
• Identify resourcing issues and collaborate with stakeholders (e.g., people managers) to ensure appropriate resourcing for assigned studies.
• Ensure study design and timelines are achievable in the local environment and meet performance expectations.
• Coordinate oversight site visits or accompanied site visits as part of country risk assessment, in alignment with ASV guidance.
• Drive recruitment at the country level by liaising with local affiliates and global functions to implement effective recruitment action plans.
• Ensure quality and timeliness of study deliverables, including:
  • Site identification, feasibility, start-up, recruitment, data deliverables, and site closures.
  • CDA delivery and negotiation (based on pre-approved parameters).
  • Country feasibility assessments in collaboration with local affiliates and global stakeholders.
  • Site selection, including Site Quality Risk Assessments and Site Qualification Visits.
  • Timely submission of applications/documents to evaluating authorities (e.g., EC/IRB, Competent Authorities).
  • Coordination of Master Informed Consent Forms (MICF) and site-level ICFs, including translations.
  • Negotiation of site study contracts and budgets in collaboration with start-up managers.
  • Preparation of local Master Clinical Study Agreements (CSA) and amendments.
  • Collection and verification of trial essential documents per ICH-GCP prior to study start.
  • Compliance with site activation projections and maintenance of study records in CTMS and local registries.
  • Oversight and coordination of monitoring activities from site activation to study closure.
  • Meeting recruitment targets and driving country/site recruitment action plans.
  • Proactive reporting of study-specific issues, including monitoring metrics, to the study team.
• Provide functional reporting to Head of Country Operations (HCO) and Line Manager (LM), including:
  • Updates on local study team performance (CRAs, CSA, etc.).
  • Regular information on study milestones, key risks, and issues at the country level.
  • Leading risk-based quality meetings and project performance reviews.
  • Reporting on research-related information, including sites, investigators, and competing studies.
  • Regular updates on project progress, risks, and action plans.
• Proactively identify and escalate potential risks at the country level, providing mitigation plans to HCO.
• Support HCO in driving country strategy to achieve goals and lead projects aligned with country objectives.
• Manage relationships with national key opinion leaders, patient advocacy organizations, and other external stakeholders impacting rare disease strategy.
• Accountable for the country’s external scientific engagement plan for assigned studies or therapeutic areas.
• Support implementation of activities associated with the external scientific engagement plan.
• Act as a mentor to Senior Manager PMCO and Country Study Manager, as needed.

Requirements

• Strong leadership skills, including the ability to make independent decisions, mentor, and coach teams.
• Ability to set goals for local study teams, prioritize tasks, and implement strategic development.
• Proven ability to lead, troubleshoot, and influence quality and delivery.
• Strong communication skills to build trustful relationships with internal and external stakeholders.
• Effective management of tense or difficult situations while keeping the team focused on goals and company values.
• Proven experience communicating with site staff, including KOLs and thought leaders.
• Excellent written, verbal, and presentation skills with good intercultural awareness.
• Excellent organizational and planning skills, including managing project budgets.
• Ability to work effectively cross-functionally and identify risks independently.
• Proven experience in oversight and leading operational aspects of all stages of the clinical trial process.
• Solid knowledge of clinical development processes with prior project/site management experience.
• Track record of ensuring GCP compliance and successful risk management of complex clinical studies.
• Comprehensive and current regulatory knowledge, including GCP.
• Experience conducting GCP or other training is a plus.
• Ability to deal with competing priorities and champion company values.
• Flexibility in schedule and willingness to travel (up to 20% during busy periods).
• Proficient with MS Office Suite (Excel, Word, PowerPoint).
• Excellent knowledge of spoken and written English.

Qualifications

• Bachelor’s Degree or equivalent in clinical practice/healthcare, life sciences, or drug development (required).
• A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) is preferred.
• Minimum of 5 years of relevant experience with a CRO or pharmaceutical company working on internal delivery models and multinational clinical studies.
• Lead CRA/management experience preferred.
• Strong project management skills.
• Experience managing high-priority/complex studies through phases 1–4, preferably in rare medical conditions.
• Previous oversight and regulatory inspection experience preferred.
• Excellent understanding of the end-to-end clinical study process, including monitoring.

Benefits

• Inclusive culture that champions diversity and collaboration, with a commitment to lifelong learning, growth, and development.
• Qualified retirement program (401(k) plan) with company contribution (hourly roles).
• Short-term incentive bonus opportunity (salaried roles).
• Eligibility to participate in equity-based long-term incentive programs (salaried roles).
• Paid vacation, holidays, and leaves.
• Health benefits, including medical, prescription drug, dental, and vision coverage.

Pay

Annual base pay ranges from $142,171.20 to $213,256.80 USD. Hourly and salaried non-exempt employees are eligible for overtime pay. Base pay may vary depending on market location, job-related knowledge, skills, and experience. Additional compensation may include short-term incentive bonuses, equity-based long-term incentives (salaried roles), retirement contributions (hourly roles), and commission payments (sales roles).