Remote Clinical Operations Manager

Summary

Join Allucent as a Clinical Operations Manager (COM) to lead and mentor Clinical Trial Associates (CTAs), ensuring the objectives of Allucent and sponsors are met. As a COM, you will provide guidance on company policies, procedures, SOPs, ICH/GCP guidelines, FDA regulations, and local regulatory bodies.

Requirements

• At least 7-years’ clinical research experience
• Prior experience as a Clinical Trial Associate, Clinical Trial Assistant, or similar positions preferred
• Experience managing teams in the Americas and EU/UK preferred
• Bachelor or higher university degree in life sciences, nursing or medical background preferred
• Experience in a leadership capacity or line management
• Strong customer service orientation
• Demonstrated professionalism and presentation of a positive image of the company
• Effective clinical monitoring skills
• Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology
• Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures
• Effective oral and written and presentation communication skills, with the ability to communicate effectively with varied audiences
• Effective organizational and time management skills
• Proven flexibility and adaptability
• Ability to work in a team and to effectively prioritize tasks
• Strong ability to work independently and problem solve
• Attention to detail
• Ability to establish and maintain effective working relationships with co-workers, managers, direct reports, internal and external clients

Responsibilities

• Manages the day-to-day functional and organizational activities of CTAs
• Is responsible for resourcing of assigned staff (Monthly Allocation Form completion)
• Oversees and manages the assigned staff workload
• Provides leadership, mentorship and career development for the assigned staff, including monitoring performance and identifying training needs
• Reviews the budgeted and recorded hours to ensure they are within acceptable working limits for active studies for the assigned staff
• Assists assigned staff in managing time and tasks to adhere to study budget and timelines
• Provides guidance to ensure that assigned staff fulfils responsibilities, to the company and the client, in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies
• Liaises with Trial Master File Management department to ensure CTAs are fulfilling filing requirements, meeting project and client timelines; attends assigned project team calls as needed to support the clinical deliverables of the project, and project team member transition meetings
• Updates Country Operating & Regulatory Requirements (CORR) as required
• Performs interviews of candidates and hiring of new CTAs
• Collaborates with Project Management department, with Medical Affairs & Pharmacovigilance department, with Quality Assurance and Compliance department
• Conducts performance reviews of assigned staff. Contributes to the process improvement initiatives
• Manages feasibilities as required
• Supervises CTAs
• Actively contribute to staff learning & development within the company
• Plans and executes training meetings

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees