Service Designer at Vodafone leading design and delivery of end - to - end experiences for products and services through collaboration with cross - functional teams.
About the role
- Global Senior Trial Delivery Manager leading Study Management Team for clinical trials in Europe and UK. Ensuring compliance with protocols and operational excellence in trial management.
Responsibilities
- Lead the Study Management Team (SMT).
- Ensure availability of required reports to support real time tracking of trial status according to trial plan.
- Manage timely and accurate documentation and communication of trial progress.
- Act as primary contact for Country and Regional staff.
- Partner with the Global Trial Lead to execute and oversee central activities.
- Ensure issue escalation and drive issue resolution.
- Establish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level.
- Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level.
- Create and update trial-specific documents as required.
- Provide central documents required for HA/EC/IRB submission.
- Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes.
Requirements
- BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- 6-8 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience.
- Strong working knowledge of ICH-GCP, local laws and regulations.
- Superior clinical research operational knowledge.
- Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
- Demonstrated effective leadership.
- Proficient in speaking and writing local country language and English.
- Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
- Travel.
Benefits
- Complies with relevant training requirements.
- Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level.
- Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes.
- Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level.
- Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit.
- Establish country budgets and monitor actuals vs. forecast for Out-of-Pocket Expenses.
- Oversee selected vendors and status of related deliverables.
- Review and approve assigned vendor invoices/spend.
- Participate in preparation for, conduct of, Health Authority inspections and internal audits.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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