Scientist, Clinical Operations (Hybrid)
Merck · North Wales, PA · 2 mo ago
$96k–$151k/yrFull-time
Job Responsibilities
- Responsible for specific clinical/scientific activities on a single study or across multiple studies, as delegated (e.g., medical monitoring, lab specimen tracking/reconciliation, adjudication support, preparation of meeting materials).
- Supports development of study protocol and related materials (e.g., ICF documents/amendments, data management deliverables).
- May interact with internal and external stakeholders (e.g., country operations, committees, vendors) in support of clinical study objectives.
- Supports development of site and CRA training materials.
- Prepares clinical narratives in support of eDMC meetings or submissions.
- Collaborate cross-functionally to monitor/track clinical study data, deliverables and/or supplies to ensure quality, completeness, and integrity of trial conduct.
- Contributes to design of vendor deliverables (e.g., EDC, laboratory, ePRO, IRT) in alignment with the protocol.
- Supports the evaluation and tracking of protocol deviations (PDs), trends and mitigation efforts in collaboration with medical monitoring teams.
Education Requirements
- Bachelor’s degree + 2 years OR Master’s + 1 year Pharmaceutical and/or clinical drug development experience.
- Degree in life sciences, preferred.
Required Skills
- Clinical Research
- Clinical Sciences
- Clinical Study Design
- Clinical Trial Development
- Clinical Trials
- Clinical Trials Operations
- Medical Writing
- Protocol Writing
- Regulatory Writing
- Trial Design
Preferred Skills
- Clinical Studies
- Clinical Trials Monitoring
- Study Management