Senior Manager leading global site activation for clinical trials at biotechnology company. Overseeing project execution, team collaboration, and strategic oversight for high profile studies.
Responsibilities
Develop the site start up strategy for each study assigned (complex, high profile)
Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions
Advocate for optimized site selection strategies
Lead the development, assessment, and alignment of site activation projections
Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF)
Partner with cross-functional and CRO partners to develop a comprehensive global country start up strategy
Monitor and maintain country intelligence data to support informed decision-making
Support regulatory submissions as needed
Ensure timely country submission deliverables
Lead and oversee all aspects of site start-up activities for complex, high profile studies
Serve as the subject matter expert for essential site documents
Lead the collection and analysis of site intelligence to support strategic site selection and site start-up
Oversee the preparation and approval of site regulatory packages
Requirements
Bachelor's degree
8+ years of relevant industry experience
Strong interpersonal and leadership skills
Ability to provide and implement operational strategic direction and guidance for respective clinical trials
Strong knowledge and a data-driven approach to planning, executing, and problem solving
Strong communication skills via verbal, written and presentation abilities
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Ability to influence and negotiate across a wide range of stakeholders
Ability to lead and develop productive study teams and collaborations
Applies advanced negotiation and interpersonal skills to vendor management
Strong technical proficiency in trial management systems (CTMS, TMF) and MS applications (Project, PowerPoint, Word, Excel)
Extensive experience in the clinical drug development process, including study start-up
Knowledge and understanding of ICH/GCP and regulatory guidelines/directives
Strong project management skills, cross-functional team interaction, and organizational skills
Line management experience preferred
Benefits
health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave) for eligible employees
Senior Manager managing creator relationships and strategies at OverCast Digital, a leading TikTok Shop Partner. Driving GMV through effective creator program management in a hybrid role.
Transportation Manager developing domestic logistics strategy for Sally Beauty. Leading transportation operations and improving service performance with a focus on cost - effectiveness.
District Manager responsible for driving sales success across diverse territories. Focusing on customer relationships and strategic initiatives while working closely with multiple stakeholders.
Care Manager 1 providing statewide care management for Medicaid enrolled members in NC. Working remotely while coordinating integrated care services and developing care plans.
Residential Manager overseeing Adult Residential Service Program in Tacoma. Responsible for supervising programs and helping clients achieve independence and quality care.
Excursions Manager responsible for managing daily tour operations and supervising staff in Hoonah, AK. Focus on guest satisfaction and operational consistency with oversight of excursions.
Responsable de programmes gérant des opérations de transformation des patrimoines pour Nhood à Lille. Pilotage des projets immobiliers mixtes avec une forte coordination entre équipes.
Associate Impact Manager at BlueOrchard contributing to ESG and impact management activities. Engaging in assessments, reporting, and enhancing impact management practices.
RN Case Manager coordinating nursing care for patients in Western North Carolina. Instructing and supervising staff while managing caseloads and assessing patients' health.
IT Manager providing leadership for the technical team managing Oracle Retail Point of Service. Engaging with business partners and driving strategic vision while managing support operations.