Manager, Clinical Science Analytics & Insights

Summary

Join Precision for Medicine's Clinical Science Analytics & Insights team as a Manager! This fully remote position (UK, Spain, Poland, Slovakia, Romania, Hungary, or Serbia) involves managing and developing a team of CSAI personnel. You will serve as a subject matter expert, ensuring projects are appropriately resourced and staff are supported. Responsibilities include performance reviews, training, compliance oversight, and contributing to departmental initiatives. The ideal candidate possesses a Bachelor's degree in a science or health-related field, 8+ years of clinical research experience (including oncology), and 2-3 years of direct supervisory experience managing CRAs. Additional requirements include experience with electronic data capture systems and proficiency in Microsoft Office. Preferred qualifications include a medical-related degree and experience with data visualization software.

Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related discipline with proficiency in medical terminology
• Minimum of 8 years of clinical research experience or proven competencies for this position
• Strong experience related to oncological clinical trials, paired with on-site monitoring experience &/or data review experience
• 2-3 years of direct supervisory experience managing CRAs is expected in candidates for this position including
• Experience with electronic data capture systems
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
• Excellent communication & interpersonal skills to effectively interface with others in a team setting
• Excellent organization skills, attention to detail & a customer service demeanor
• Professional use of the English language; both written & oral
• Ability to occasionally travel domestically & internationally including overnight stays
• Experience creating effective development programs for clinical staff
• Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards

Responsibilities

• Day-to-day management of direct reports &/or company/departmental initiatives; managing assigned workload and ensuring deliverables are achieved
• Accountable for the development of direct reports by setting goals, conducting performance reviews, creating development plans & mentoring
• Responsible to ensure onboarding of direct reports including ensuring proper functional training customized to the individual to ensure role consistency
• Communicate & support strategic direction to direct reports including supervision, goal setting, career development planning, training, & mentoring with the purpose of meeting company, department & direct report goals
• Accountable to ensure directs reports function in compliance with policies, SOPs, federal & local guidelines & GCPs
• Accountable for the retention of high quality CSAI staff
• Participates as a member of the CSAI functional management team providing day-to-day support to CSAI resource and supporting the management of departmental KPIs & objectives/goals
• Support Project & Financial Management as needed (e.g., monthly invoicing)
• Provide subject matter expertise to other departmental functions as applicable
• Collaborate to support internal CSIA and cross-functional departmental communication
• Create/contribute & support the development/modification of policy & processes related to the CSAI function
• Prepare routine & ad hoc reports as needed
• Support a continuous risk management approach to the CSAI function
• Support and manage complex challenges related to people and process
• Ensure systems & process are working to produce quality work efficiently
• Support appropriate resource allocation & utilization including forecasting for direct reports considering scope of work changes as work progresses
• Participate in business development activities including input into proposals & cost estimates as well as participation in bid defense meetings
• Participate in department, company, vendor, and client meetings as needed
• May develop &/or present departmental trainings
• Contribute to & support company & CSAI process improvement initiatives
• Contribute to & support implementation of alternative solutions to address business & operational challenges
• Collaborate with Learning & Development to develop & support training initiatives and also support the development/review of global SOPs, FORMs &/or CSAI functional tools &/or training
• Consult with project teams & sponsors as needed on project related issues
• Perform other duties as assigned

Preferred Qualifications

• Medical related degree, RN, OCN, RPH, PharmD, etc
• Database build experience
• Experience with data visualization software such as JReview
• Working knowledge of FDA & ICH-GCP, relevant SOPs & regulatory guidance with a well-rounded knowledge of the entire clinical trial process & working understanding of clinical research functional departments
• Highly organized, ability to set priorities and possesses excellent problem-solving skills
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied
• Demonstrates ability to adjust to multiple demands & shifting priorities
• Ability to apply financial management skills at the functional area project level
• Excellent presentation, verbal, & written communications skills