Key Experiences During Program
Work with cross-functional team to conduct clinical studies, including preparation of meeting materials, safety and medical monitoring, preparation of status update reports, and study close-out activities.
Support Medical Lead with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs. Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety. Assist in communicating a clear overview of trial results.
Provide support for Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
Contribute to protocols, clinical study reports, IBs, ICFs, training documents, and other clinical documents under the direction of the Medical Lead.
Lead interactions with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives.
Represent Vertex to outside personnel in the development of clinical protocols and study conduct.
Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.
Present and support preparation of scientific material for conference presentations or publications.
Collaborates with cross-functional groups at Vertex for assigned programs as the clinical representative and liaison to the therapeutic area.
Learning about other functions within Global Medicines Development & Affairs (GMDA) through ongoing interactions and rotational experiences