Manager, Clinical Science Analytics & Insights

Precision for Medicine is looking for a Manager to join our Clinical Science Analytics & Insights team. The position can be covered fully remotely in the UK, Spain, Poland, Slovakia, Romania, Hungary or Serbia.

Position Summary:

The Manager, Clinical Science Analytics & Insights (CSAI) is responsible for the management and career development of CSAI personnel and serves as a departmental subject matter expert (SME) supporting departmental initiatives, business development, departmental best practices and training, etc. to support and strengthen the quality and productivity of CSAI. This position requires the ability to independently lead, manage, and motivate a team of CSAI (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on data quality. Specific focus will be to ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful. In addition, this position will provide CSAI with career development and support, to minimize turnover and maintain high levels of employee satisfaction.

Essential functions of the job include but are not limited to:

• 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

Qualifications:

Minimum Required:

• 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: 

o Experience creating effective development programs for clinical staff. 

o 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

Other Required: 

• 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

Preferred:

• 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 

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