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Manager, Study Start-up

Waltham, MA 02451

Posted: 09/05/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 614320 Is job remote?: Yes Country: United States

Job Description

Position Overview: 
As Manager, Study and Site Start Up (SSU), you will be responsible for the effective planning, execution, and oversight of study feasibility, site activation, and patient recruitment and retention deliverables.  
 
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 

Pay ranges between $75-90/hr based on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Waltham, MA

Discover exciting job opportunities in the vibrant area surrounding Waltham, Massachusetts! Known for its rich history, picturesque scenery, and bustling economy, Waltham offers job seekers a unique blend of innovation and tradition. Home to renowned universities, cutting-edge technology companies, and a thriving cultural scene, this city has something for everyone. Explore job listings in this region and unlock the door to a career filled with growth, charm, and endless possibilities. From strolling along the Charles River to catching a game at Fenway Park, there's no shortage of enchanting experiences waiting for you in the Waltham area. Start your job search today and embark on a rewarding career journey in one of the most inviting locations in the Northeast.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.