Sr. Clinical Trial Manager

Proclinical is currently seeking a Senior Clinical Trail Manager for a pharmaceutical company located in Massachusetts. Successful candidate will be responsible for ensuring trial adherence to ICH/GCP/local regulations. Additionally, candidate will take part in negotiation of vendor scope of work, budgets, performance management, issue resolution, and quality assessments.

Job Responsibilities:

• Developing study plan(s) including key milestones and timelines.
• Ensuring country and site selection meet study requirements.
• Developing and managing clinical trial budgets.
• Ensuring accuracy and timeliness of vendor and site payments.
• Ensuring availability of clinical/non-clinical supplies.
• Providing input for clinical regulatory documents.
• Participating in development and testing of clinical systems.
• Guaranteeing internal and external systems are updated in a timely manner.
• Maintaining and overseeing the Trial Master File.
• Authoring/co-authoring protocols in collaboration with Medical Monitor and other stakeholders.
• Identifying, addressing, and communicating quality and compliance concerns.
• Ensuring inspection readiness internally and externally.
• Providing regular study status updates and as requested.
• Communicating effectively with internal and external study personnel.
• Providing study-specific direction, mentoring, and management to other staff as appropriate.
• Managing direct reports as assigned.
• Other duties and responsibilities as required.

Skills and Requirements:

• BA/BS required.
• 5+ years' experience managing clinical trials within biotech, pharmaceutical or medical device environment.
• Experience in rare disease not required but preferred.
• Excellent verbal and written communication skills.
• Experience in a start-up environment preferred.
• Must be pro-active team player, flexible, and open to change.
• Knowledge of GCP and ICH.
• Experience developing study plans and budgets including risk mitigation strategies.
• Experience in multiple phases of research preferred.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Miles Tobin at (+1) 617-545-5922 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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