About the job
We are seeking an experienced and highly organized Senior Project Manager to oversee and drive clinical research, scientific, and regulatory projects, with involvement across study design, data review, medical writing, and scientific strategy. This role plays a central coordinating and integrative function, working closely with cross-functional teams to ensure timely, compliant, and high-quality delivery of clinical and scientific outputs.
Key Responsibilities
- Lead and manage projects supporting clinical research activities, including clinical study planning, execution, and reporting, ensuring alignment of timelines, milestones, dependencies, and risks
- Coordinate cross-functional stakeholders including clinical operations, medical affairs, biostatistics, data management, regulatory, vendors, and external freelancers to ensure alignment on scope, timelines, and deliverables
- Support clinical study design activities, including coordination of protocol development, review of study objectives, endpoints, and key design elements in collaboration with clinical, statistical, and regulatory teams
- Coordinate, and where required author and review, high-quality medical writing deliverables including clinical study reports, study protocols, informed consent forms, investigator brochures, annual safety reports, and related documents in compliance with global and local regulations
- Support ongoing clinical data review activities, including review of listings, tables, figures, and interim outputs to ensure medical and scientific coherence, data quality, and consistency with protocol and analysis plans
- Conduct systematic literature searches and critical literature reviews to support study rationale, protocol background sections, data interpretation, and scientific strategy
- Leverage digital and AI-enabled tools (where appropriate) to support literature screening, document drafting, data summarization, and workflow efficiency, in alignment with internal governance and compliance standards
- Develop scientific and (where applicable) non-promotional content for congresses, publications, investigator meetings, and internal scientific communications
- Coordinate creation of scientific communications and training materials for internal and external stakeholders, including healthcare professionals and field teams
- Support regulatory dossier preparation, quality control, and review for submissions (e.g., EMA, US FDA), including coordination of responses and document updates
- Maintain structured summaries and repositories of relevant medical and scientific literature and study documentation
- Ensure adherence to SOPs and participate in the development, review, and continuous improvement of procedural documents
- Support audits and inspections, including preparation of documentation and coordination of CAPA activities where required
- Assist with administrative processes such as purchase orders, contracts, and invoice verification using internal systems (e.g., SAP)
Required Skills & Experience
- PhD/PharmD/MSc / MPharm / MPH in Life Sciences, Clinical Research, Pharmaceutical Sciences, Biotechnology, or related fields
- 6-8 years of relevant experience
- Proven experience in project management within a pharmaceutical, biotech, CRO, or clinical research environment
- Prior involvement in clinical trials in any capacity (e.g., clinical operations, medical writing, regulatory affairs, data management, biostatistics, or study coordination) is strongly preferred
- Demonstrated understanding of clinical study design principles and clinical data review processes
- Strong ability to interpret, analyse, and present clinical, medical, and scientific data
- Excellent organizational, planning, and stakeholder management skills, with the ability to manage multiple priorities simultaneously
- Excellent written and verbal communication skills with strong attention to detail
- Hands-on experience with literature searches and critical appraisal of scientific publications
- Comfort and interest in using AI- or digital-assisted tools for scientific writing, literature review, and data synthesis, within regulated environments
- Solid understanding of global regulatory frameworks and guidelines (e.g., ICH, FDA, EMA)
- Self-motivated, adaptable, and comfortable working independently and collaboratively in a fast-paced environment
