Senior Manager, Study Start Up

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)