Job description
Job Description
General Summary:
Working directly with Investigative Sites, the Site Activation Senior Manager will independently perform activities at a site level associated with Study Start-Up including regulatory document collection, preparation of Ethics submission documents, Informed Consent Form development and essential document package review. This role may also provide assistance to Site Activation Managers (SAMs) for trial activation activities in various countries and help ensure milestones are achieved within time, cost and quality parameters. May also be responsible for coordinating site activations across all countries for a respective trial
Key Duties and Responsibilities:
- Responsible for activation of assigned study sites and countries to meet project timelines
- Interacts with other departments to communicate and negotiate timelines, including Clinical Budget Management and Regulatory Affairs
- Facilitates Informed Consent Form review and negotiation process for study, country and site templates
- Communicates project risk and mitigation strategies to Study Team members effectively
- Contributes to problem solving and resolution efforts including management of risk, contingencies, and issues
- Identifies quality issues within the study to implement appropriate corrective action plans
- Facilitates generation and finalization of documents and applicable translations for global regulatory and EC submissions according to applicable SOPs and WIs
- Builds, cultivates and manages relationships with key study personnel, including Study Coordinators and PIs
- Works directly with Investigative Sites for all aspects of Study Start-Up including: activation timeline development, regulatory document preparation and collection, IRB/EC submissions as well as facilitating IRB/EC responses
- Ensures data integrity by facilitating data cleaning efforts for internal information systems, setting standards for data entry and maintenance
Knowledge and Skills:
- Solid understanding of relevant Clinical Research and Study Start-Up processes and industry trends
- Solid understanding of key regulatory authorities and regulatory requirements, ICH Guidelines, and GCP's governing the Start-Up of clinical trials
- Experience with investigative site Start-Up documents
- Good understanding of clinical trial execution
- Fluency in English
- Ability to work well independently and in a team environment
- Ability to effectively manage multiple priorities and to meet deadlines
- Strong verbal and written communication skills to exchange complex information with others
- Strong project management skills
#LI - Remote
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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