Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Manages the site compliance teamand ensures compliance with all appropriate guidelines for legal, regulatory and company policies/procedures. Responsible for implementation ofquality programs, processes and procedures that ensure compliance. Collaborates with the site teamteam to provide continuous oversight to meet requirements for eCRF completion timelines and compliance to protocol required data endpoints. Drives operational quality and process improvement initiatives through training at site level. Provides support to the siteregarding Quality Management System (QMS), quality control of data received from the sites and identification and/or support in reporting of Quality Events. Has oversight of the Site Level Quality Review process at site level. Collaborates with the Regional Manager Operational Compliance to support compliance objectives and address identified quality or operational issues.
Day to day responsibilities:
- Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations.
- Approves courses of action on salary administration, hiring, corrective action, and terminations.
- Reviews and approves time records, expense reports, requests for leave, and overtime.
- Promotes all aspects of company Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good ethical and regulatory standards.
- Tracks individual targets and output of Site compliance co-ordinators
- Completes SLQR or delegates completion and reviews checklist, escalating trends in non-compliance
- Performs regular quality control and oversees that quality of data is accurate, on time and adheres to latest approved SOPs, COPs standards, GCPs, Local Regulatory and protocol.
- Validates and reviews quality of site study data, ensuring accuracy of data entered and source documents and eCRF discrepancies.
- Participates in the development and maintenance of a dashboard for flow of source and eCRFs and queries, ensuring that this is provided in a timely manner.
- Collaborates with relevant stakeholders and departments ensuring that issues impacting the business are highlighted and handled as required.
- Monitors quality and training processes to ensure appropriate timelines are met (e.g., QMS, CAPA, functional GCP and other mandatory training).
- Liaises with monitors, client representatives and internal and external clients.
- Clarifies concerns related to eCRF completions. Resolves queries.
- Identifies trends in data queries and escalates appropriately. Reports QE’sas appropriate.
- Ensures that quality is at the forefront of all activities through review and interpretations of audit reports, quality statistics and operating procedure robustness. Follows up on quality issues.
- Ensures robust application and compliance with Good Clinical Practice and Data Protection Acts or SOPs, QA and applicable regulatory guidelines.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years).
1+ year of leadership responsibility
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, and Abilities:
- Industry knowledge of quality compliance
- Good knowledge of data protection and general local labor laws
- Ability to understand and interpret protocol
- Knowledge of clinical trial process and data management, clinical operations, quality management and systems applications to support operations
- Basic knowledge of SOPs, GCPs and local/international regulations
- Ability to analyze data, share information and make recommendations for improvements
- Appropriate MS Office, computer, EDC and eCRF skills
- Good English language and business acumen
- Good organizational, problem solving, prioritizing and planning skills
- Solid time management skills and ability to adhere to project productivity metrics and time lines
- May require IT/SQL skills
Policy and Strategy:
Administers and executes policies, processes, and procedures that affect subordinate employees and the workflow of the unit. Requires full knowledge of own area of functional responsibility.
Management Role:
Directly supervises individual contributors, administrative support and / or entry-level professionals.
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequently drives to site locations and frequently travels both domestic and international.
Physical Requirements:
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Moderate mobility required.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others, relates sensitive information to diverse groups both internally & externally.
- Ability to apply basic principles to solve conceptual issues.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.