Manager – Data Compliance

Job title:

Manager – Data Compliance

Company:

Thermo Fisher Scientific

Job description

Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob DescriptionAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.Alongside clinical research through our PPD® clinical research portfolio, our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the futureThis is a meaningful but truly exciting opportunity to join Synexus as an Manager – Data Compliance for our dedicated research site in Gdynia, Poland.Summarized Purpose:Manages a teams typically within multiple countries or regions and ensures compliance with all appropriate guidelines for legal, regulatory and company policies/procedures. Develops and implements quality programs, processes and procedures that ensure compliance. Collaborates with Central DC team to provide continuous oversight to meet requirements for eCRF completion timelines and compliance to protocol required data endpoints. Provides innovative solutions and training to drive operational quality and process improvement initiatives. Provides leadership to the department regarding Quality Management System (QMS), quality control of data received from the sites and identification and/or support in reporting of QI.Key roles and 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 DCs.
• Prepares reports and escalate any non-conformance to targets.
• Maintains delegation logs by updating active employees and leavers and ensuring that all DCs are added to all relevant logs. Maintains a tracker for all the studies and sites relevant delegation logs and system and protocol training.
• 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.
• Develops, maintains and produces 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 resolved.
• Monitors quality and training processes to ensure appropriate timelines are met (e.g., QMS, CAPA, functional GCP and other mandatory training).
• Serves as a liaison with monitors, client representatives and internal and external clients.

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 5+ years).
• 1+ year of leadership responsibility

Knowledge, Skills and Abilities:

• Strong industry knowledge of quality compliance
• Solid knowledge of data protection and general local labor laws
• Proven ability to understand and interpret protocol
• Strong understanding of the clinical trial process and data management, clinical operations, quality management and systems applications to support operations
• Advanced knowledge of SOPs, GCPs and local/international regulations
• Strong data analytic skills with ability to present/share information and make recommendations for improvements
• Strong MS Office, computer, EDC and eCRF skills
• Good English language on strong business acumen
• Good organizational, problem solving, prioritizing and planning skills
• Strong time management skills and ability to adhere to project productivity metrics and time lines

Expected salary

Location

Gdynia, pomorskie

Job date

Tue, 01 Oct 2024 22:00:11 GMT

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