Clinical Trials Scientific Affairs Supervisor

Job Title: Supervisor Clinical Trials Scientfic Affairs

Department: Scientific Affairs

Location: Remote | United States

Hours Per Week: 40

Schedule: Days, Monday – Friday

SUMMARY

The Clinical Trials Scientific Affairs Pre Award Supervisor is responsible for the daily management of activities within the team, ensuring that RFP reviews and determination of testing requirements are conducted according to established procedures. Serves as a subject matter expert within the team, provides support with queries and escalations as needed. Works closely with team members from the Commercial, Operational and Scientific teams to deliver on ACM business objectives.

RESPONSIBILTIES

• Maintain daily departmental performance by managing resources, prioritizing tasks, and developing and monitoring metrics. 
• Oversee daily management of the team to effectively handle day-to-day workload. 
• Hire, coach and develop direct reports, including definition of role and responsibilities, training, development and performance management. 
• Facilitate communication as a point of escalation or strategic point of contact for the department. 
• Identify, lead, and/or participate in cross-functional process improvement initiatives to optimize operational capabilities. 
• Promote and uphold a high performing culture through effective talent planning, selection, onboarding and continuing education. 
• Curate and deliver comprehensive training plans and materials to foster successful onboarding and employee performance. 
• Provide ongoing coaching and mentorship supported by routine performance metrics to identify clear performance feedback and career development plans. 
• Foster professional development through continuous coaching and performance management 
• Partner with HR to ensure talent management, performance, employee relations, and development activities are aligned with organizational policies, employment legislation, and best practices. 
• Investigate testing requirements within a clinical trial protocol and help determine testing facilities to identify required testing and associated nuances for the timely and accurate response for proposals 
• Review and prepare pricing documents, as needed, noting and correcting any discrepancies 
• Maintain relationships between ACM and referral laboratories 
• Provide scientific/ technical information to compile client RFPs and RFIs 
• Provide feedback to the manager to address analytical trends or issues, to support business needs 
• Assist in coordinating the testing methods with referral labs, as needed 
• Obtain and document referred testing information throughout the course of the active trial, including contracting with referral labs 
• Assumes responsibility for channeling information to and from Laboratory Operations and Sales 
• Alert leadership to any issues during the life cycle of study related and testing needs 
• Alert leadership to any issues with referral laboratories, assist with root cause analysis 
• Suggests and helps implement improved work methods and ways to increase efficiency, reduce costs, and solve operational problems 
• Liaison with internal and external partners and participate in client teleconferences to address new business needs or ongoing study issues 
• Understands and follows company policies and procedures and while respecting patient confidentiality 
• Provide consultation to clinical trials operations and external clients, as needed 
• Works with leadership to update global SOPs, as needed 
• Triage upcoming work and determine staffing capabilities and workload for assignments 
• Serve as subject matter expert to internal and external clients 
• Serve as escalation point for internal and external clients 
• Assists in development, maintenance and updates to templates and tools 
• Perform other duties as assigned. 

This job description is not intended to be exhaustive. The employee may be required to undertake any other duties that are reasonably required and are commensurate with the skills, experience and level of responsibility of the role. 

MINIMUM QUALIFICATIONS

• Bachelor’s degree in a relevant scientific discipline or a minimum of 3 years of experience as a Clinical Laboratory Scientist 
• Minimum of 5 years of laboratory experience in a clinical setting, or a relevant regulated environment 

PREFERRED QUALIFICATIONS

• 4 yrs clinical trials experience preferred
• Strong interpersonal and communication skills 

• Strong time management and organizational skills 

• Ability to manage multiple projects with tight deadlines 

• Ability to work independently and in a team setting 

• Proficient in Microsoft Office 

• Generalist laboratory experience 

• Ability to lead and positively motivate others 

• Models a positive and solutions-oriented mindset 

• MT (ASCP) Certification – Preferred 

EDUCATION:

LICENSES / CERTIFICATIONS: 

PHYSICAL REQUIREMENTS:

For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

PAY RANGE:

The posted pay range is a good faith representation of potential base pay for this position. It may be modified in the future and eligible for additional pay components. Individual annual salaries/hourly rates could vary based on position details and FTE. Pay is determined by considering factors including, but not limited to, experience, relevant qualifications, specialty, internal equity, locations, and contracts.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.