POSITION SUMMARY:

The Clinical Study Team Manager is responsible for assuring the study team is accountable for performing assigned responsibilities in compliance with project plans, federal regulations, GCP and good medical practice. This position reports directly to the Director of Clinical Operations.

EXPERIENCE AND SKILLS:

• Customer service
• Microsoft Office proficiency
• Working knowledge of Clinical Conductor CTMS
• Understanding of research principles, protocols, and basic finance
• Excellent communication and interpersonal skills in person, email and telephone etiquette
• Ability to work effectively with a team
• Ability to manage small projects personally and work independently
• Memory to retain information and know where to research answers
• Time management skills
• Close attention to detail and strong organizational skills to deliver high quality work within project timelines
• Demonstrates strong analytical, problem-solving skill
• Self-motivated
• Must be results oriented, multi-tasking and a quick learner

EDUCATION AND EXPERIENCE:

• Minimum 5-6 years of experience in clinical research
• Strong knowledge of relevant regulations ICH/GCP and FDA guidelines
• Effective site management and organizational skills/ability to meet key study milestones
• Bachelor’s degree preferred

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands and wrists
• Ability to lift and/or move up to 25 pounds.

POSITION RESPONSIBILITIES

• Reviews study compliance against protocol, SOPs, regulations and ICH/GCP guidelines
• Acts as a primary liaison with CRO/sponsors; establishes quality guidelines to ensure clinical study vendors are adhering to the agreed upon timelines
• Ensures timely responses to clinical site staff and all regulatory agencies
• Develop strong, collaborative working relationships with CROs, sponsors, investigators, and other essential staff members
• Assembles and coordinates clinical trial study teams of study coordinators and other personnel needed to support the execution of the clinical study
• Oversees overall study progress, data collection, and cleaning activities for all study trials
• Interacts and coordinates with sponsor on study specifics
• Prepares study reports and provides ongoing updates for leadership team/meetings
• Develops best practices and SOPs
• Provides clinical leadership to CROs and sponsors
• Effectively leads and manages a team of direct reports
• Oversees leadership of the Study Management team while ensuring site training/communications are occurring
• Interviews and onboards new hires for the Study Management team
• Conducts continuing performance management and annual reviews of the Study Management team
• Participates in and assists Director of Clinical Operations with preinitiation and other study related meetings
• Ensures staff work is “inspection ready” at all times
  Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands and wrists
• Ability to lift and/or move up to 25 pounds