Clinical Program Manager

Clinical Program Manager

Function:

Type:

Experience:

Role Overview:

We’re looking for a hands-on Project Manager to own end-to-end delivery of clinical and real-world evidence (RWE) projects and Patient Support Programs. You’ll lead RFPs and quotations, manage vendors, drive timelines and budgets, provide client-facing updates, and ensure quality and compliance across every workstream. The ideal candidate is an Excel power user, comfortable with AI-enabled workflows, and experienced across clinical trials and RWE studies with working knowledge of ICH-GCP.

Responsibilities:

• Own full project lifecycle

  from scoping and proposal (RFPs, quotations) through start-up, execution, close-out, and lessons learned.

• Plan and track

  timelines, budgets, resourcing, and risk/issue logs; run weekly/biweekly internal and client stand-ups with crisp status reporting.

• Vendor management:

  source, evaluate, contract, and oversee CROs, data providers, biostats/analytics partners, and tech platforms; monitor SLAs and quality.

• Client engagement:

  serve as the day-to-day point of contact; translate objectives into clear deliverables and present progress, insights, and mitigations.

• Cross-functional coordination

  with Medical, Biostats/HEOR, Clinical Ops, Data Science, Pharmacovigilance, and Regulatory to unblock dependencies.

• Financial stewardship:

  manage SOWs, change orders, invoices, and margin tracking

• Lead Patient Support Programs (PSPs):

  design and operationalize PSPs (enrolment, onboarding, adherence, persistence, reimbursement/navigation), ensuring medical accuracy, data privacy, and ethical promotion standards.

• Compliance & governance

  : ensure PSP materials, scripts, and data flows meet ICH-GCP spirit, local regulations, and internal SOPs (incl. consent, opt-in/opt-out, pharmacovigilance intake, and data retention).

• Operational excellence:

  implement templates, trackers, and AI-assisted workflows to improve speed, accuracy, and traceability.

Required Qualifications

• 3–7 years

  in

  Medical Affairs, Clinical Operations, or RWE

  project management.

• Proven experience

  managing

  clinical trials and RWE studies

  (e.g., non-interventional, retrospective/prospective observational, registries).

• Working knowledge of ICH-GCP

  and related ethics/regulatory frameworks; familiarity with data privacy (e.g., HIPAA/GDPR equivalents).

• Advanced Excel

  (pivot tables, Power Query/Power Pivot, lookups, nested formulas; bonus: VBA) and strong

  PowerPoint

  /reporting skills.

• Comfort with AI-enabled workflows

  (e.g., drafting, QC checklists, reconciliation, risk sensing) and openness to adopt new tools.

• Excellent communication

  (written, verbal, and presentation) with strong stakeholder management.
• Demonstrated ability to

  manage vendors

  , budgets, risks, and change controls in a multi-project environment.

Key Skills

• Project planning & execution
• Budgeting & SOWs
• Vendor & contract management
• Risk/issue management
• Stakeholder communication
• Quality & compliance (ICH-GCP)
• Cross-functional leadership
• Advanced Excel
• AI-assisted operations
• Presentation & reporting