Manager, Study Start-up

Peak Performers has partnered with a global biopharmaceutical company to assist in their search for a Manager, Study Start-up. In this contract position, you will be responsible for the effective planning, execution, and oversight of study feasibility, site activation, and patient recruitment and retention deliverables.

Major duties

• Perform proactive risk assessment to anticipate study specific challenges.
• Develop and validate overall study timelines and enrollment rate.
• Oversee all site start up activities, including execution of CTAs, contracts, and investigator payments.
• Track progress vs. plan and develop and execute mitigation strategies to ensure the study remains on track.
• Develop recruitment and retention strategies and materials, and obtain internal approval of any patient facing materials.
• Participate in the selection and management of CROs/Vendors who are responsible for specified task / activities/ data/ associated with study and site start up, periodically assessing the performance of the vendors and to promote continuous improvement.
• Identify and implement industry best practice solutions to optimize site engagement.
• Identify industry innovation opportunities in SSU and bring best practice solutions.
• Engage and develop strong working relationships within clinical study teams, Contracts and Budgets, Clinical Supply and Logistics, Legal and Regulatory to generate the best outcomes for study and site start up activities.
  
  

What are we looking for?

• BS with a minimum of 8 years of experience in a pharmaceutical industry or other clinical research setting with clinical trials.
• Experience in developing metrics and key performance indicators to track study progress and vendor performance.
• Ability to effectively establish priorities and develop objectives, goals and action plans to meet or exceed expectations within a fast-paced matrixed environment.
• Excellent verbal/written communication skills and ability to influence at all levels across functions and build effective relationships.
• Strong understanding of regulations and GCP requirements for drug development, advanced knowledge of clinical operations and industry standards, and advanced skills partnering with CROs and other third-party vendors.
• Experience in global site start up.
• Experience working on Phase I-IV studies in CNS therapeutic area preferred.
  
  

About This Position

• Rate: $78.00-$88.50/hour
• Length of engagement: ~6 months
• Days/Hours: Monday-Friday/8am-5pm
• REMOTE
  
  

The Peak Performers difference

• Excellent medical health, dental & vision insurance at 60 days
• Our employees may choose to participate in a 403(b) retirement plan
• Qualified applicants with chronic medical conditions and/or disabilities receive priority placement
• We pay weekly through direct deposit
• In business since 1994 and thousands of job placements
  
  

All employment offers are contingent on the successful completion of a pre-employment criminal background check, in compliance with all applicable federal and state laws.

Applicants for employment with Peak Performers must possess work authorization that does not require sponsorship for a visa now or in the future.

Peak Performers is an equal opportunity employer and will consider all applicants without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Peak Performers does not accept unsolicited resumes from headhunters, recruitment agencies or fee-based recruitment services.

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