Senior Manager, Study Start Up
Primary Location: Czech Republic, Remote Job ID R0000036332 Category Clinical TrialsAbout this Role
Key Accountabilities:
Oversight of activities
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 startup 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 to CRO counterpart and colleagues (e.g., 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
Collaborative relationships
Collaborates effectively with cross-functional teams, CRO partners, and regional colleagues to advance study start-up activities, oversee site activation processes, and ensure timely execution of clinical trials that align with project objectives and regulatory requirements across diverse global landscapes.
Skills:
Demonstrates ability to analyze complex situations, develop comprehensive plans, and oversee their execution across multiple partners and regions.
Excels in building and maintaining productive relationships with diverse teams and stakeholders, both internal and external.
Applies expertise to define scope, set timelines, monitor progress, and solve challenges in complex, multi-faceted projects.
Exhibits strong ability to lead in a matrix environment, communicate effectively at all levels, and present complex information to various stakeholders.
Knowledge and Experience:
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
Education:
Degree (BSc) or equivalent experience gained through time in industry (>5yrs)
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