Senior Manager, Site Start Up

Parexel•Southport, NC

About The Position

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel FSP has an exciting opportunity for a candidate with strong experience in Clinical Study Startup!

Requirements

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.
The candidate must have a good working knowledge of clinical operations, clinical processes and medical terminology.
Excellent knowledge of GCP and regulations
Degree (BSc) or equivalent experience gained through time in industry (>5yrs)

Nice To Haves

Experience in project management, CRO experience, change management or process design are beneficial
Experience of controlled drug substances processed would be beneficial
Experience of developing junior members of staff would be beneficial
Experience of Regulatory Inspections

Responsibilities

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.