Clinical Operations Manager (Mexico)
Allucent, Mexico

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

Summary:

The Clinical Operations Manager (COM) will provide leadership, mentorship; training and career development for assigned Clinical Research Associates (CRAs), Local Site Activation Staff (LSA Staff) and Local Clinical Trial Assistants (LCTAs) to assure the objectives of Allucent and the sponsor are met. The COM will provide guidance to ensure that 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.

Key Responsibilities:

• Manages the day-to-day functional and organizational activities of CRAs, LSA Staff and LCTAs.
• 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 Project Management department to ensure CRAs are fulfilling monitoring requirements and 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.
• Liaises with Site Activation department to ensure LSA staff is fulfilling submissions 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.
• Liaises with Trial Master File Management department to ensure LCTAs 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 amp; Regulatory Requirements (CORR) as required.
• Performs interviews of candidates and hiring of new CRAs, LSA staff amp; LCTAs.
• Collaborates with Project Management department, with Medical Affairs amp; Pharmacovigilance department, with Quality Assurance and Compliance department.

• Other responsibilities as required.

Requirements

• At least 7-years’ clinical research experience
• Bachelor or higher university degree in life sciences, nursing or medical backgroundpreferred
• Experience in a leadership capacity or line management

Skills:

• 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-wor

Job Rewards and Benefits