Contract Clinical Study Manager, RWE

BioTalent; United States; On-site; USD 125,000 - 140,000; Part time

Job summary

A leading international biopharmaceutical company in the United States is seeking a Real-World Evidence Clinical Study Manager. This senior role involves driving the success of global RWE studies, ensuring compliance and operational excellence. Candidates should have 7+ years' experience in pharma or related fields, with strong project management skills. The role offers a competitive salary between $125,000 and $140,000 and allows for minimal travel.

Qualifications

• 7+ years of experience in pharma, biotech, healthcare, or research.
• 4+ years of experience in clinical research or real-world evidence generation.
• Proven ability to manage complex, multi-stakeholder studies.

Responsibilities

• Lead planning, design, and execution of real-world studies.
• Ensure studies are delivered on time and within budget.
• Provide strategic input on study design and evidence generation.

Skills

Scientific insight

Operational excellence

Collaboration

Influencing skills

Attention to detail

Education

Advanced degree (MBA, MS, or equivalent)

Job description

We’re partnering with a leading international biopharmaceutical company that’s dedicated to transforming the lives of people living with rare diseases. With an expanding portfolio in immunology, hematology, and specialty care, they’re committed to developing innovative therapies that address high unmet medical needs.

We’re seeking a Real-World Evidence (RWE) Clinical Study Manager to join their growing Global Real-World Evidence (GRWE) team. This role offers a unique opportunity to shape how real‑world data informs clinical development, regulatory submissions, and ultimately, patient outcomes.

What You’ll Do

In this strategic and hands‑on role, you’ll combine scientific insight with operational excellence to drive the success of global RWE studies. You’ll:

• Lead the planning, design, and execution of real‑world studies that generate meaningful evidence for clinical and regulatory use.
• Ensure studies are delivered on time, within budget, and in compliance with ethical and regulatory standards (GCP, FDA/EMA).
• Provide strategic input to senior leadership on study design, operational feasibility, and evidence generation approaches.
• Oversee CRO and vendor partnerships, ensuring high‑quality deliverables and proactive issue resolution.
• Manage project finances, risk mitigation, and study governance to maintain operational excellence.
• Foster collaboration and innovation across cross‑functional global teams.
• Lead study team meetings and contribute to a culture of scientific rigor and excellence.

Travel is minimal (approximately 5–10%).

What You Bring

We’re looking for someone who thrives in a mission‑driven, fast‑paced environment and brings both scientific depth and operational strength.

Required

• Advanced degree (MBA, MS, or equivalent) and 7+ years of experience in pharma, biotech, healthcare, or research.
• 4+ years of experience in clinical research, real‑world evidence generation, or related fields.
• Proven ability to manage complex, multi‑stakeholder studies from concept through execution.

Preferred

• Strong written, verbal, and presentation skills.
• Deep attention to detail with scientific and operational rigor.
• Collaborative mindset with the ability to influence across a matrixed organization.
• Experience managing large budgets, timelines, and CRO/vendor partnerships.
• Familiarity with observational research (EHR, claims, registries, chart reviews).
• Experience supporting regulatory submissions and interacting with global health authorities (FDA, EMA).
• Background in immunology, hematology, or rare diseases a plus.

Why This Role?

If you’re passionate about turning data into real‑world impact—and want to contribute to life‑changing therapies for rare disease communities—this role offers the opportunity to lead with purpose, collaborate globally, and make a tangible difference.

Interested?

We’d love to tell you more. Please apply or reach out confidentially to discuss how your experience aligns with this opportunity.

Job Details

• Seniority level: Director
• Employment type: Contract
• Job function: Project Management
• Industries: Pharmaceutical Manufacturing and Biotechnology Research

United States, $125,000 - $140,000.