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Clinical Trial Manager (1524)
Ref No.: 18-28445
Location: Andover, Massachusetts
Location: Memphis, TN or Andover, MA

Role Overview:

The Manager, Global Trial Support is responsible for ensuring operational deliverables are met according to timelines, budget and quality standards for global clinical studies. Responsible for providing support to Clinical, Medical & Scientific Affairs to ensure efficient and effective conduct of clinical studies. This position may have management responsibilities for Contract & Budget Specialists, Clinical Trial Assistants (CTAs), eTMF Administration, and/or Clinical Trial Management System (CTMS) under the direction of the Director, Global Trial Support. This position has professional responsibilities for managing, training and the career development of direct reports.

Responsibilities: (Please specify % amount against each responsibility)
Ø Provide leadership and strategic direction to direct reports in order to achieve operational objectives through effective coaching and mentoring. (20%)
Ø Support the development of quality processes to ensure accurate and complete essential documents for global clinical studies. (20%)
Ø Ensure Clinical Trial Support staff are providing appropriate levels of study support using a harmonized methodology on a global basis following applicable regulations and SOPs. (20%)
Ø Report on performance to plan and proactively remove obstacles that impede workflow. (15%)
Ø Provide support to management with regard to the implementation of the Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) System. (15%)
Ø Ensure direct reports are following all applicable regulations and SOPs and always audit ready. (10%)

Location: Memphis, US or Andover, US

Education: Master's degree in life sciences preferred; or combination of education and experience.

Experience: > 7 years' experience in study management and/or study support within the clinical trial industry. Experience managing a remotely based diverse team as well as medical device trial experience is preferred.

Competences: (1) Ability to lead multiple complex projects (2) Lead others in the development of problem solving and judgement skills (3) Lead/Mentor/Coach staff (4) Professional communication skills with strong oral and written English (5) Serve in a leadership capacity for Global Trial Support (6) Advanced knowledge and interpretation of US Code of Federal Regulations, ISO 14155, ICH GCP (7) Knowledge of Essential Documents. (7) Experience with Microsoft Excel, Word, PowerPoint, and Outlook (8) Experience with organization of paper/electronic files (9) Record of excellent performance in a similar role and process the knowledge and technical skills to be successful

Physical Demands: Sitting most of the day; light lifting.

Travel Requirements: up to 25%