Clinical Operations and Project Management:

• Transition of pre-clinical assets into clinical development stage
• Efficient planning, set-up, conduct and reporting of national and international clinical trial(s), Phase I – III and Investigator-sponsored trials, healthy volunteer and first-in-human trials, evaluating New Chemical Entities (NCE), biologicals, biosimilars, vaccines
• Management and logistics of clinical drug supply and central laboratory including samples

Document management:

• Drafting and review of relevant documents such as Clinical Trial Protocol, Investigator's Brochure, Informed Consent Form

Regulatory support:

• Management of Clinical Trial Applications and interaction with Ethics Committees and Institutional Review Boards 

Third Party management and oversight:

• Selection, qualification, management and oversight of vendors/Clinical Research Organizations as well as clinical trial sites (hospitals and practices) 

Building in-house capabilities and process management:

• Building and leading global interdisciplinary project and program teams
• Evaluation of existing processes and implementing the fit-for-purpose set-up and clinical team
• Mentoring and development of staff in Clinical Operations roles