Experience in a trial start-up team or similar roles on global clinical trials
Project management and CRO experience preferred
Working knowledge of clinical operations and medical terminology
Strong understanding of GCP and regulations
Beneficial experience with controlled drug substances
Experience in developing junior staff and handling regulatory inspections
Responsibilities
Advance study start-up activities for outsourced trials by driving timelines and execution
Oversee start-up activities with CRO partners to ensure smooth progress
Communicate effectively with CRO counterparts and internal teams on study requirements
Implement unique methodologies to drive site activation and compliance
Lead daily project activities in collaboration with Clinical Trial Managers
Evaluate performance, monitor challenges, and timelines versus the plan
Coordinate regional information and collaborates across departments to ensure study success
Benefits
Collaborative work environment fostering professional relationships
Opportunities for developing team members
Exposure to diverse aspects of clinical trial management
Engagement in innovative start-up methodologies
Access to industry-leading training and development programs
Full Job Description
Essential Functions
Trial Start Up Group
Accountable for advancing study start-up activities for outsourced trials by understanding the objectives and assisting in the review and approval of the plan for country and site activation.
Laser focus approach to oversight of start up activities within our CRO assigned programs. Working with the CRO partners to maintain timelines and successful execution.
Accountable for all matters related to CRO partners study start-up requirements and must be able to communicate issues effectively CRO counterpart and colleagues (eg CTM) as required.
Adopting a unique start-up methodology to drive site activations through oversight of all activities, driving delivery and compliance across the assigned regions and CRO partners
Leads day to day project activities in the matrix, by working closely with the Clinical Trial Manager and CRO counterparts.
Oversees start up activities with one or more CRO partners at a program and/or study level
Acting as a Senior Manager with regional colleagues co-ordinate regional information to present based on oversight of regional colleagues (if required) depending on size of study/complexity.
Evaluate performance and solve acute challenges and monitor timelines and progress vs. plan
Specialist knowledge of start-up requirements & activities in each country and region, country requirements, inner workings of a country/ regulatory landscape.
Works collaboratively with functional colleagues to ensure successful completion of study start up, fostering productive working relationships with other collaborators within Regulatory, Legal, Contracts and Clinical Operations
Reviews program or study specifics to define project scope, timelines, and deliverables from project initiation and maintains/monitors throughout
Reviews and approves start up plan(s) that clarify study specific tasks, general timelines, and processes related to overall study start up.
Liaise with other project team members to ensure cohesive and clear project performance and expectation
Required Knowledge, Skills, and Abilities
Extensive pharmaceutical or related industry experience
Extensive previous experience of working in a Start-up team, Clinical Trial Specialist, CRA, Clinical Trial Manager or similar having worked on global clinical trials.
Experience in project management, CRO experience, change management or process design are beneficial
The candidate must have a good working knowledge of clinical operations, clinical processes and medical terminology.
Excellent knowledge of GCP and regulations
Experience of controlled drug substances processed would be beneficial
Experience of developing junior members of staff would be beneficial
Experience of Regulatory Inspections
Required/Preferred Education and Licenses
Degree (BSc) or equivalent experience gained through time in industry (>5yrs)
