Sr Manager - Clinical Operations - Italy

We are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products. Our services range from supporting the largest brands in the industry, to providing fully outsourced functional services, to the most recently approved genetic therapies in orphan populations. The work we do positively impacts patients’ lives all over the world.

UBC has a position for an Experienced Clinical Operations Manager to join a team of very well established COMs throughout Europe.

Brief Description:  

Fulfill general responsibilities with regard to hiring, training, resourcing, coaching, performance management, and functional delivery of respective staff. Direct reports may include CTS, CSS, CRA and other clinically focused personnel. Participate in frequent discussions about operational delivery measurements and work in collaboration with the leadership team to develop and/or refine policies, procedures, and business work plans.
 

Specific job duties:

• Manage team of clinical operations professionals and promote an effective and collaborative environment in which best practices are shared. 
• Conduct hiring, training, and evaluation of staff.
• Ensure induction and orientation of newly hired staff.
• Maintain oversight of productivity and quality metrics.
• Hold 1:1 discussions and team meetings.
• Develop and/or refine employee’ skills.
• Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to UBC SOPs.
• Provide objective performance reviews, deliver feedback, and make recommendations for promotion. 
• Provide on-going coaching to each team member concerning quality, reliability, accountability, and productivity. 
• Oversee resolution of issues related to employee performance. 
• Take formal actions to improve performance, when necessary.
• Perform trend analysis for attrition and turnover and make recommendations for corrective measures.
• Ensure staff assignments are appropriate to meet departmental utilization targets.
• Ensures allocated resources are aligned with current and forecasted work in terms of capability, quantity, timing, and efficiency.
• Drive department strategy and reinforce key elements to team.
• Lead initiatives that enhance departmental performance and/or lead to process improvement across UBC.
• Understand department role in inspection readiness and educate team.
• Support teams in sponsor/regulatory audits, as required. 
• Ensure key performance metrics, service levels, contractual obligations, and performance guarantees are met.
• Understand revenue drivers and costs for the department and contribute to budgetary discussions, as appropriate, at each country level to ensure profitability.
• Act as functional area lead in country wide business development activities, as appropriate.
• Support cross-departmental training initiatives.
• Train and mentor new Clinical Managers.
• Serve as country level liaison for client issues.
• Act as role model for the team and reinforce UBC core values.
• Be innovative and wholeheartedly support change.
• Other duties as assigned by management.

Supervisory Responsibility:  

• 10-18 Direct Reports 

Desired Skills and Qualifications:

• Advanced Degree preferred, bachelor’s degree or equivalent experience required.
• Significant clinical research experience (comparable to 7 years) including remote and clinical monitoring and experience in all phases of study life cycle, including start up, interim and close out
• Line management experience (2 years) appropriate to the size and complexity of the clinical management group in the designated country/region
• Demonstrated ability to work with diverse, global teams
• Excellent mentoring/leadership/supervisory skills
• Advanced knowledge of clinical trials monitoring: remote and on-site
• Strong knowledge of FDA/ICH regulatory guidelines
• Working knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics, and regulatory/medical writing)
• Solid problem-solving and analytical skills with willingness and ability to detect process gaps, challenge assumptions, and drive change and improvement
• Ability to work in a team environment under high pressure situations
• Strong influencing and negotiation skills
• 10% travel as required

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.  We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.

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