Manager Clinical Operations - Robsco Inc.

Position Description

Job Title: Manager, Clinical Operations
Location: Southborough, MA
Job Type: Direct Hire

Job Description:

The Manager, Clinical Operations manages and coordinates aspects of Clinical Operations activities including successful execution of projects, resourcing and personnel activities to assure the successful completion of projects and achievement of departmental goals; promote SOP compliance. Serves as a primary point of contact for CRA staff, clinical project managers, executive staff and clients.

Coordinate all aspects of Clinical Operations including, but not limited to, maintenance and revision of standard processes and procedures; coordination of project timelines, deliverables and schedules; department budget management; communication with client, clinical project managers and CRAs to promote project schedule adherence; staff management.

Review staff/department billable percentages.

Assist the Director, Clinical Operations with the proposal/budget development process.

Participate in internal, client/sponsor, sales, scientific and other presentations as required.

Periodically review and revise:
- appropriate standard operating procedures
- divisional procedures and policies

Establish standard guidelines and timelines for divisional responsibilities and modify, as needed, for each project.

Assist in development of case report forms and other relevant project documents and tools.

Assist in the design and implementation of data collection forms and data collection strategies.

Assist business development with presentations, sales related brochures, proposals, identification of
prospective clients, etc.

Manage and assist CRA activities with project team members to ensure efficient clinical monitoring and effective project completion.

Work closely with clinical project managers to promote operations efficiency, teamwork and high morale.

Manage personnel activities and provide guidance for professional development of staff (coordinate resource distribution across projects, interviews, make hiring recommendations, lead disciplinary actions, and delivers performance reviews).

Additional Duties and Responsibilities:
Provides clinical project coverage for CPMs and CRAs
May assist in the development, implementation and assess the training program for Clinical Research Associates in
compliance with GCP and industry standards.


Requirements:

Bachelor’s degree; minimum 3 years direct industry experience including 1 year of project and / or staff management experience.

Other Skills and Abilities:
Must have a strong understanding of Medical Terminology, Physiology, and Pathophysiology. Must have strong working knowledge of Good Clinical Practices.
Must have strong management skills.
Must have: strong organizational and time management skills; the ability to multi-task; the ability to work effectively in a fast-paced environment; strong written, verbal communication and diplomacy skills.

Preferred Qualifications:
MS; 2 years experience in project and/or staff management; 3+ years experience in a CRO; very strong management skills.

How to Apply

Application Instructions / Send a Resume