JOB TITLE – Clinical Operations Manager

GENERAL SUMMARY OF DUTIES – Manages study operational plans to include project timelines and quality of deliverables. Manages the planning, organization, and daily operations of the clinical and administrative activities of a complex research site. Develops, implements, and monitors programs, policies and procedures to ensure the highest quality of participant and sponsor satisfaction.

REPORTS TO – VP & General Manager

SUPERVISES – Clinical Managers to include: Unit, Laboratory, Investigator, Rater, Pharmacy, and Project Managers and any clinical personnel as necessary

DUTIES INCLUDE, BUT ARE NOT LIMITED TO:

• Oversees the supervision of staff, operational efficiency, and best utilization and productivity of staff

• Maintains frequent contact with CROs and Sponsors to assess performance

• Reviews and refines clinical operational plans for study start up and study progression

• Coordinates internal and external clinical development activities of all staff involved in the conduct of assigned clinical trials

• Assists with protocol and medical issue resolution

• Identifies and provides solutions to clinical trial issues and/or risks

• Oversees site’s adherence to GCP, protocol specific, and ACMR regulations

• Represents Clinical Operations in cross-functional initiatives

• Provide and/or facilitate training to clinical study teams on assigned protocol specific and ACMR guidelines and procedures

• Work closely with other teams in the organization, e.g. quality, regulatory, etc.

• Develop and provide input into non-project related activities and development process, procedures, and guidelines

• Ensure use of resources is efficient and identify and apply funding if necessary

• Sets work schedules, delegates assignments and tasks

• Evaluates employee performance and disciplinary action

• Recognizes and rewards desirable individual and team performance

• Makes value-oriented decisions to achieve strategic business results; Ability to be flexible, make quick decisions and seamlessly navigate risks and ambiguity while effectively navigating a dynamic project environment

• Motivates and mentor employees to achieve peak productivity and performance;

• Trains and educates staff as appropriate in clinical trial procedures, protocol review, procedural completion

• Coordinates in-service training, evaluations, continuing education, orientation, competency reviews, and other related training functions.

• Qualitative Key Performance Indicators:

  • Study Results and Participant status measured

  • Risk and Issue Management is carried out on all projects

  • Adherence to quality assurance standards clearly measured and monitored

  • Staff performance measurement

• Other duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES – This position requires the following minimal requirements:

• Knowledge of sponsors & study requirements;

• Knowledge of participant evaluation procedures;

• Knowledge of clinical operations and procedures;

• Knowledge of staff hiring procedures;

• Skill in examining and re-engineering operations and procedures, formulating policy, and developing and implementing new strategies and procedures;

• Skill in employee development and performance management

• Ability to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments;

• Ability to foster a cooperative work environment;

• Ability to develop and present educational programs and or workshops;

• Ability to organize training programs and competency reviews of nursing staff.

• Skill in organization and record maintenance;

• Skill in developing and maintaining effective working relationships with supervisors and co-workers;

• Ability to complete paperwork with precision and attention to detail;

• Ability to react calmly and effectively in emergency situations;

• Ability to interpret, adapt and apply guidelines and procedures;

• Ability to work independently as well as functioning as part of a team;

• Ability to communicate clearly orally, as well as through writing.

A successful candidate will be responsible for ensuring Participants, Sponsors and Staff are cared for by following the guidelines provided by Management. The ideal candidate will be a detail oriented individual that is adaptable to change and has a strong background in Supervision and Organizational Success. The ideal person is a team player able to work in a fast-paced environment and is willing to adhere to the guiding principles of ACMR.

Service Excellence: We believe all relationships with co-workers, sponsors, and subjects are partnerships. We demonstrate service excellence through a personal commitment to producing high quality, high value work, and delivering on time and on target results for every partner.

Safety: We believe that physical and psychological safety are foundational for a healthy organization. We proactively identify and mitigate safety risks as part of our daily work and value those who speak up for safety.

Resilience: We believe resilience is critical for doing our best work. We demonstrate resilience by remaining flexible, adapting to sudden change, and bouncing back from difficult situations with grace and confidence.

Team Orientation: We believe that having a team orientation leads to individual and organizational success. We demonstrate team orientation by working collaboratively and leveraging collective knowledge, ideas, and strengths to achieve a common goal.

Ethical Behavior: We believe the pillars of ethical behavior are integrity, honesty, respect, courtesy, and caring. We demonstrate ethical behavior by modeling professional standards of conduct.

Mutual Respect: We believe that mutual respect cultivates a supportive workplace. We demonstrate mutual respect by embracing diverse perspectives, sharing ideas, and trusting in each other’s abilities.

Open Communication: We believe that open communication results in a rich and rewarding dialogue that allows for the flow of energy and creativity. We demonstrate open communication by listening for understanding, speaking up without fear, freely sharing experiences, and soliciting ideas and opinions from others.

EDUCATION - BA/BS Required; Master’s Degree Preferred.

EXPERIENCE – At least three (3) years of experience in clinical research

CERTIFICATE/LICENSE – CPR Training Provided.

PHYSICAL DEMANDS/WORKING CONDITIONS – Standard operating hours are Monday through Friday, 8:00a.m. to 5:00p.m. May be required to complete job-related tasks outside of that time frame, in excess of a standard 40-hour work week. Requires prolonged walking, standing, some bending, stooping and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Requires occasional lifting of boxes up to 50 pounds. Work is performed in a medical office environment and includes exposure to blood-borne pathogens and bio-hazardous materials. This role requires the ability to work with a broad range of personalities, situations and psychiatric disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.