Senior Manager, Early Clinical Development, Clinical Pharmacology Studies
$294,150–$356,442 year
On-siteWarsaw, Mazovia, Poland
Job Summary
Develop and refine clinical protocols and informed consent documents for early-phase trials, presenting them to governance committees to ensure scientific rigor. Collaborate with data management specialists to design CRFs and contribute to Data Review Plans that support data integrity. Author and review Clinical Study Reports and regulatory submissions, including INDs, IBs, and DSURs, to facilitate global health authority approvals. Build training materials and present at Investigator Meetings and Site Initiation Visits to equip study sites. Monitor clinical data trends and review narratives to maintain patient safety. This role requires a Life Sciences degree and 2+ years in early drug development, with 10–20% domestic and international travel and hybrid onsite requirements.
Required Qualifications
- Hold a degree in Life Sciences (MD, PhD, PharmD, MS, RN or equivalent)
- 2+ years of experience in early drug development, clinical pharmacology, or clinical research
- Know your way around GCP/ICH guidelines
- Understand what good study design really looks like
- Can hold your own in the detail - you spot things others miss, and you care about getting it right
- Are comfortable navigating ambiguity - shifting priorities don't throw you, they energise you
- Bring solid medical writing skills
- Can translate complex science into clear, compelling documents
- Are confident using Microsoft Office tools
- Are confident using data review platforms
- Turn raw information into insight
- 10 – 20% Domestic and international travel required
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