Senior Manager, Study Start Up - FSP

When our values align, there's no limit to what we can achieve.
 
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.

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 US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.