A great company in Framingham, MA is seeking a Manager, Clinical Affairs.
Here are the details:
Summary
The Manager, Clinical Affairs manages and coordinates aspects of Clinical Affairs activities including successful execution of projects 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.
Essential Duties and Responsibilities include the following:
Coordinate aspects of Clinical Affairs including, but not limited to, maintenance and revision of standard processes and procedures; coordination of project timelines, deliverables and schedules; communication with client, clinical project managers and CRAs to promote project schedule adherence; staff management. Participate in internal, client/sponsor, sales, scientific and other presentations as required. Review and revise (as needed) appropriate standard operating procedures and divisional procedures and policies Establish standard guidelines and timelines for divisional responsibilities and modify, as needed, for each project. Assist in development of project documents and tools. 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.
Qualification Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions.
Education and/or Experience:
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, 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. Must have professional demeanor and appearance.
Preferred Qualifications:
MS; 2 years experience in project and/or staff management; 3+ years experience in a CRO; very strong management skills.
Ability to travel up to 25%.
Reports to the Director, Clinical Affairs
If interested, please forward your resume, salary requirement (or history), work authorization and relocation considerations (if any) to resumes@workwonders staffing. net
Here are the details:
Summary
The Manager, Clinical Affairs manages and coordinates aspects of Clinical Affairs activities including successful execution of projects 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.
Essential Duties and Responsibilities include the following:
Coordinate aspects of Clinical Affairs including, but not limited to, maintenance and revision of standard processes and procedures; coordination of project timelines, deliverables and schedules; communication with client, clinical project managers and CRAs to promote project schedule adherence; staff management. Participate in internal, client/sponsor, sales, scientific and other presentations as required. Review and revise (as needed) appropriate standard operating procedures and divisional procedures and policies Establish standard guidelines and timelines for divisional responsibilities and modify, as needed, for each project. Assist in development of project documents and tools. 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.
Qualification Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions.
Education and/or Experience:
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, 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. Must have professional demeanor and appearance.
Preferred Qualifications:
MS; 2 years experience in project and/or staff management; 3+ years experience in a CRO; very strong management skills.
Ability to travel up to 25%.
Reports to the Director, Clinical Affairs
If interested, please forward your resume, salary requirement (or history), work authorization and relocation considerations (if any) to resumes@workwonders staffing. net