Clinical Team Lead/Clinical Study Manager
Job Code: CSA0418B

The CTL will manage the execution for the clinical component of study protocols within an assigned area or region. The CTL will ensure that studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. May act as a CTL for large scale projects under the supervision of more senior staff. May also serve as a Senior Clinical Research Associate (Sr. CRA) as needed. The CTL will also handle the following:

• Establish appropriate clinical tools and processes for the study team to support the execution of clinical deliverable and study timelines.
• Manage clinical study set-up, follow-up study activities through ongoing tracking and review and report progress to management.
• Collaborate with other internal functional groups to manage study issues and support milestone achievements.
• Ensure high performance and efficiency of the clinical team by providing ongoing mentoring, training and support; schedule co-monitoring site visits as needed.
• Develop the clinical risk management plan; coordinate clinical issue escalation and resolution.
• Identify quality issues within the study through regular review of team communications;
• implement appropriate corrective action plans as needed.
• Track clinical budget through regular review of project reports.
• Establish partnerships with applicable client representative(s) as appropriate.
• May conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas.

This position may be filled at the Clinical Team Lead or Clinical Study Manager level depending on education and experience.

Qualifications

• Prefer a BA/Bs in health care or other scientific discipline.
• 3 years clinical monitoring experience with one year in a project leadership role.
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• In depth therapeutic and protocol knowledge as provided in company training.
• Computer proficiency in use of Microsoft Office.
• Strong written and verbal communication skills.
• Excellent organizational and problem-solving skills.
• Effective time management skills; Ability to manage competing priorities.
• Strong presentation skills.
• Effective mentoring and training skills.
• Ability to lead and motivate a team.
   

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