Senior Manager Clinical Operations

Role Summary

Reporting to the Director, Clinical Operations, the ideal candidate would be someone who thrives in a small, fast-paced environment and wants to play a key role in moving Clinical Operations forward wear wearing multiple hats. Primarily focused on CRA management and ensuring the integrity of the monitoring process is protected, the candidate brings a unique blend of experience and skill. This is an opportunity to be part of a pivotal program and to see effective management produce critical results.

Responsibilities

• Direct, hands-on oversight of daily CRA operations
• Induction of new CRA‚Äôs (onboarding, training, SOP requirements)
• Conduct oversight visits to assess CRA performance
• Involvement in the interview and selection process of CRA‚Äôs
• Assist in audit preparation activities
• Work closely with Director, Clinical Operations and others to develop meeting and training materials, guidelines, templates, etc.
• Develop and directly manage study metric trackers; including monitoring visit report tracker, protocol deviation tracker, action item follow-up, with support from Clinical Trial Manager (CTM) or others
• Develop and maintain effective and positive relationships with Investigators
• Identify and escalate risks in study conduct and assist in mitigation, when appropriate
• Collaborative and effective management of cross-functional study team activities as well as communication with and management of external vendors and stakeholders) e.g. CROs, IRBs/ECs and other external partners
• Communicate trial status within and outside study team to ensure cross-functional alignment of expectations, priorities, and deliverables (enrollment, monitoring activities, site compliance and data metrics)
• Anticipates, recognizes, and manages issues/risks and recognizes the need to seek assistance from or inform Senior Management
• Implement clinical project plans in accordance with key study documents (e.g. Protocols, project plans and timelines, etc.) as well as corporate and regulatory objectives
• Facilitate internal project team meetings
• Other duties and responsibilities as required

Skills

• A positive, forward-thinking attitude
• Excellent organizational skills; including tracker building and maintenance
• Strong leadership, mentoring and motivational skills
• Proficient knowledge of MS Office software
• Master-level monitoring and site management skills
• 20% travel requirement

Qualifications

• Bachelor‚Äôs degree in Science, Nursing or Pharmacy or similar
• 10+ years clinical operations experience; including roles as a Clinical Research Associate (CRA), Monitoring Manager, Clinical Operations Manager or similar/Clinical Trial Manager/Study Management
• Working high-level knowledge of ICH/GCP and CFR 21 and Part 11
• Ability to effectively and succinctly communicate key messages to Senior