Clinical Operations Manager

hace 7 meses

Desde casa, México Allucent A tiempo completo

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Clinical Operations Manager (COM) to join our A-team (hybrid*/remote). As a COM at Allucent, you 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.

**In this role your key tasks will include**:

- 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 & Regulatory Requirements (CORR) as required
- 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 CRAs, LSA staff & LCTAs
- Actively contribute to staff learning & development within the company
- Plans and executes training meetings
- Other responsibilities as needed.

**Requirements**:
**To be successful you will possess**:

- At least 7-years’ clinical research experience
- 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
- 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

**Benefits**

**Benefits of working at Allucent include**:

- 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 e

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