Senior Manager, Study Start Up - FSP
Primary Location: United States, Remote Job ID R0000036989 Category Clinical TrialsAbout this Role
Remote position- can be US or Canada*******
The Senior Manager, Site Start Up will oversee a portfolio of client studies where the client have given operational responsibility to our CRO partners for trial execution. As an expanding capability, the Senior Manager, Site start Up will support development of infrastructure, processes, teams and appropriate technology to assist in the effective oversight of out- sourced studies. Additionally, this role will work collaboratively with the CRO project teams to maintain timelines and ensure that start-up activity is progressing as expected per the startup plan. Where delays occur, they will work with the Project Teams/Oversight Manager to mitigate delays and risks and ensure alternative plans for maintaining start up delivery are implemented. May manage a team of Oversight Managers (e.g., regional allocations) to support program delivery with our CRO partners in successful execution of awarded studies. This new capability will accelerate trial set up, allow more confidence in trial enrolment, and improve our timelines for execution. Ultimately the group will increase the quality, improve speed and efficiency of our clinical trials execution.
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.
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.
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.
Compliance with Parexel standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
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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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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