Senior Study Manager - FSP

at  Parexel

United States of America, Remote
Additional Locations: Remote - United States of America
Job ID R0000027492
Category Clinical Trials

JOB SUMMARY:

The Senior Study Manager (SSM) leads and manages the tactical execution of one or more clinical studies of moderate complexity from study startup through database release and inspection readiness to ensure timely delivery of quality study data.

• Provide strategic advice and expertise on potential collaborations
• Provide project management to increase efficiencies
• Process streamlining and reduce timelines
• Monitor KPIs and program needs
• Provide Training and responding to queries
• Improve Outcome reporting
• Providing accurate and timely reports to monitor research collaborations progress

Key Accountabilities:

SKILLS:

• Must be fluent in English
• Detail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management)
• Ability to interpret study level data and translate and identify risks
• Ability to proactively identify and mitigate risks around site level in study execution
• Country level cultural awareness and strong interpersonal skills
• Keen problem-solving skills
• Excellent communication skills, both written and verbal

Knowledge and Experience:

• Extensive global clinical trial/study management experience
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• Demonstrated study management/leadership experience
• Demonstrated oversight of CROs
• Demonstrated experience in managing per subject costs, vendor and ancillary, and monitoring costs projections and spend
• Understands how to work with vendors to accomplish tasks
• Understands feasibility of protocol implementation

EDUCATION:

• Bachelor’s of Science degree or Nurse – minimum of 3 years clinical project management/clinical study management experience and minimum 5 years clinical research operations experience

Parexel is hiring a sponsor dedicated Senior Study Manager to support the research collaboration center of excellence for a key FSP account.