Clinical Study Start-up Manager

Manager, Study-Start Up

Duration: 6-months

Location: Hybrid in Waltham, MA

Responsibilities:

In this role you will work with the cross functional Clinical Study Team and the CRO/Vendors to:

• 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. You will continuously 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

Qualifications:

• 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