Clinical Research Operational Compliance Manager
This job has been closed.
Synexus offers a comprehensive benefits package that includes medical, dental, and vision insurance offerings, life and disability insurance offerings, 401K, paid time off, and various other benefits and discount programs!
Synexus is an Affirmative Action and Equal Opportunity Employer.
We are seeking an Operational Compliance Manager to join our team with Optimal Research. This is a remote position with up to 50% travel.
The purpose of this role consists of:
- Leading and executing an operational quality compliance framework within the Optimal business.
- Driving and delivering operational quality and process improvement initiatives,
- Ensuring quality training and compliance across the business to increase operational quality, efficiency and long term business success.
- Providing consultation on operational quality, risk and regulatory and legislative compliance to sites / functional departments, include a focus on GCLP and GCP.
- Communicating and collaborating with Director of Operational Compliance to ensure highest level of efficiency and success of the compliance activities within Optimal and the regional business.
- Acting according to the company values: Patient Engagement, Integrity, Expertise, Customer Service and Empowerment
- Maintain a quality and compliance role within operations, separate from quality control (QC) and routine operational activities
- As part of the management, provide quality focused support to the business so that regulatory compliance and commercial objectives are achieved.
- Establish and maintain processes, procedures and minimum expectations for operational compliance (OC), including, but not limited to:
- OC activities and reviews
- Process for OC assessments /activities including scope/purpose/responsibilities
- Optimal Business OC plan
- Process for OC and RC output reporting.
- Support the reporting and follow up of Quality Issues and CAPAs from all sources within the Optimal business
- As required for serious quality issues, facilitate and report root cause analysis to aid CAPA definition and process improvement, where applicable.
- Assist regional operational staff with CAPA definition to ensure adequacy, robustness and compliance with Standard Operating Procedures (SOPs), regulations and best practice
- May perform other duties not specifically listed in the job description as assigned by the company
- Identify OC performance metrics on data generated within operational compliance and provide required metrics reports to management, as appropriate
- Provide training on functional GCP and GCLP, and other compliance and quality related topics, as required, to improve quality and expertise within the operation of the regional research centres
- Support the Synexus QA function with regards to notification, preparation and facilitation of client audit and regulatory inspections, investigations of non-compliance and tracking and follow up of regional CAPA status ensuring timely completion of quality related tasks.
- Maintain effective relationships internally and externally, for efficient and effective delivery of service
- Collaborate with CRAs/ Internal/External auditors/ Site Managers/Directors to ensure that the site Quality issues are dealt with appropriately and communicated to the relevant team members
- Support development and delivery of client governance/quality agreements in conjunction with QA and operational management.
- Brief Compliance Team at start of each year on objectives, if applicable
- Ensure regular team meetings are in place and actions taken
- Lead by example, acting in accordance with our values, developing and coaching your team with the goal of being a high performance group
- Provide quality focused support (GCP and GCLP) to the business so that regulatory compliance and commercial objectives are achieved.
- Maintain a CAPA owner listing and robust mechanisms for ensuring quality findings and resultant CAPAs are addressed, implemented and effective. Escalate issues to Managing Director and Director of Operational Compliance
- Ensure operational quality, patient safety and data integrity are at the forefront of all activities through review and interpretations of quality reports (e.g. audit reports inspection output, complaints) and specific activities undertaken via regional operational compliance.
- Support Synexus internal governance structures within the region to facilitate quality, process improvement and compliance within operations.
- Comply with company quality framework, FDA, SOPs, GCPs, GCLP, QA and all applicable Regulatory body guidance and international standards
- Safeguard confidentiality of staff, patient and sponsor matters as required by regional GDPR and Good Clinical Practice expectations
- Present a professional and positive image of Synexus at all times
- Take ownership of own personal development by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations
- May perform other duties not specifically listed in this job description as assigned by the company
- Bachelor’s degree or relevant college/university degree or similar with a minimum of 3 years’ experience within quality/ compliance in the clinical research industry, or an equivalent combination of education and experience is required.
- 3+ years' experience with GCLP and GCP guidelines and quality regulations/expectations pertaining to clinical trials highly preferred.
- In depth knowledge and understanding of the requirements, best practice and organisation of a clinical research site.
- Exposure to internal audits as well as Regulatory Body inspections will be an advantage.
- Experience in training other members of staff at all levels.
- Willingness to travel regionally and international on a regular basis.
- Personal skills including assertiveness, persistence, flexibility, highly organised and detail oriented
- Experience in managing stressful situations and handling controversial issues whilst firmly adhering to the principles of the regulations and guidelines.
- Ability to work independently, with minimal supervision, and be confident to make local decisions and escalate accordingly
- Excellent communication skills and the ability to manage upwards successfully
- Listen actively to colleagues, patients and external contacts and clarify as appropriate
- Delivers clear and concise instructions and ensures that important information from management is shared with employees and others as appropriate
- An understanding and experience of working and communicating within a matrix management environment.
- Experience of working within a highly regulated environment.
- Understand requirements and maintain commercial confidentiality.
- Safeguard confidentiality of staff, patient and sponsor matters as required by regional Data Protection, Good Clinical Laboratory and Good Clinical Practice expectations.
- Excellent Interpersonal, leadership, consultative and management skills
- A strong team player, with the ability to work independently
- Uses knowledge and charisma rather than position, power, or coercion to influence others
About The Company
Join Synexus as we expand and become an important part of a well-respected and growing company that believes the details of your career are every bit as critical as the work you do!
Synexus is the world’s largest site network, with more than 195 sites and 1,500 employees globally. We provide customers with access to more than 100 million patients in key clinical development markets including Europe and the United States. Synexus is the leader in outsourced trial management services to the pharmaceutical, biotechnology and medical device industries. We have completed over 2,500 clinical trials in our 20+ years and operate from over 80 site network locations across the US!