The Manager, Clinical Operations, is responsible for monitoring services for ProSciento and its clients. Coordinates with finance, budgeting, and operations to ensure adequate resource planning requirements and monitoring logistics, and with third party vendors for acquisition of contract Clinical Research Associates (CRAs). Provides oversight of monitoring services and monitoring operational logistics (resource allocation, scheduling). Responsible for embedding quality into ProSciento’s monitoring services. Leads the management of monitoring staff activities required to conduct clinical trials in accordance with ICH/GCP guidelines, the company’s values, policies, and procedures.

DUTIES AND RESPONSIBILITIES:

• Develops monitoring tools, templates, and processes to support early/late phase clinical trials monitoring.
• Supports planning and implementation of activities required to conduct and monitor complex clinical trials, and ensures compliance with GCP, FDA, and other applicable regulations.
• Responsible for oversight of contracted clinical monitors, including initial qualification, re‑assessment at appropriate timeframes, and managing performance.
• Provides direct supervision of staff, including creation of individual development plans, fostering team building, positive communication, and corporate culture.
• Executes responsibilities to lawful and ethical standards.
• Supports the planning and organizing of operational components required to conduct and complete monitoring of all clinical trials for which ProSciento is contracted for monitoring responsibilities.
• Fosters teamwork, open communication, and a positive work environment for monitoring staff.
• Collaborates with key department stakeholders (medical staff, clinical study and project management, data management, clinical operations, and quality management.
• Supports development of department Standard Operating Procedures (SOPs) (via electronic document management system) and manages the performance of extensive quality control of study documents and data. This may include but is not limited to the following: protocol specific source documents, inclusion/exclusion verification, source data, and Case Report Form (CRF) review/verification, and monitoring of investigator initiated trials.
• If required, contributes to monitoring duties. This may include but is not limited to the following: site qualification visits, pre-study visits, site initiation visits, routine monitoring visits, and close out visits.
• Tracks monitoring metrics and takes corresponding action when metrics are outside of agreed thresholds.
• Monitors expenses and resource utilization during study conduct.
• Participates in department and management meetings.
• Evaluates monitoring quality and provides formal feedback to monitoring staff and management.
• Assists in or delegates clinical skills training to monitoring staff.
• Ensures that all monitoring staff maintain a high level of clinical research monitoring skills appropriate to their role and responsibility.
• Establishes a standard of excellence in clinical performance and serves as an example of clinical skill requirements, judgment, and responsibility.

Supervisory Responsibilities:

Directly supervises clinical research associates (monitors). Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION:

Qualifications:

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 enable individuals with disabilities to perform the essential functions.

Education/Experience:

Bachelor’s degree in healthcare, health or sciences related field, or medical experience e.g., Nurse, Respiratory Therapist, etc. and 8+ years’ related experience including experience in a project management or study coordinator role, and/or bedside clinical experience as a nurse, PA, or Physician Investigator conducting clinical research studies. A minimum of 3 years as a CRA is required. Thorough understanding of Good Clinical Practices (GCP) and applicable FDA rules, guidance, and governance as it relates to early phase human clinical trials.

Language Ability:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Math Ability:

Ability to work with mathematical concepts such as probability and statistical inference, as well as possess an understanding of algebraic functions. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills:

To perform this job successfully, an individual should have knowledge of Microsoft Office 365 software.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities

required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand; walk and use hands to finger, handle, or feel. The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl.

By executing this job description, you acknowledge that these are the duties you presently are expected to perform and are performing. As noted above, the Company has the ability to modify your job duties at its discretion. Nonetheless, in the event this job description at any time differs from the duties you actually are performing, please notify Human Resources.

KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIRED

Competencies:

• Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources.
  • Managing and Measuring Work: Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; monitors process, progress, and results; designs feedback loops into work.
    • Building Effective Teams: Blends people into teams when needed; creates strong morale and spirit in his/her team; shares wins and successes; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates a feeling of belonging in the team.
      • Motivating Others: Creates a climate in which people want to do their best; can motivate many kinds of direct reports and team or project members; can assess each person’s hot button and use it to get the best out of him/her; pushes tasks and decisions down; empowers others; invites input from each person and shares ownership and visibility; makes each individual feel his/her work is important; is someone people like working with.
        • Peer Relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.
          • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.

CONDITIONS OF EMPLOYMENT

• Verification of educational requirements, employment history, professional references, and certifications/training and U.S. work authorization.

WORKING CONDITIONS AND PHYSICAL EFFORT

• Work is normally performed in a typical interior/office work environment, remotely or in a hybrid arrangement based on approval from the department manager/supervisor.

The above job description does not imply these outlined duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

ProSciento reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and company.

ProSciento is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.