eTMF Specialist
Boston, MA, US
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.
What we offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."
Main Responsibilities
- TMF Management and Reporting: Handles and maintains electronic TMF and electronic internal repository according to ICH/GCP guidelines and applicable regulations/ standards. Responsible for preparing the periodic internal reports on eTMF healthiness and serves as an escalation point for the study team members involved in eTMF management. Liaise with the TMF vendor as required. Supports the study teams on eTMF audit and inspection readiness activities.
- Due Diligence: Participates in Due Diligence activities related to TMF. Supports the team on gap analysis/ verification activities on TMFs acquired through acquisition.
- Meetings: Organizes the periodic TMF Oversight meeting with the applicable parties. Ensure the required action items are distributed to the study teams and escalated as required.
Purpose
This position will oversee the global eTMF (electronic Trial Master File) operations for GRD R&D including providing support to all study teams members involved in eTMF management. Responsible for creation and revision of all eTMF associated procedures, ensuring they are up to date and compliant with the applicable regulations.
This position will assume the leadership role for global eTMF operation to ensure the quality KPIs are met and eTMFs are inspection ready at all times.
• Global oversight of the eTMFs, ensuring that the study teams are maintaining inspection ready files across all programs.
• Establish KPIs and metrics for documents filed in the eTMF to improve performance, quality, risk mitigation and contingency planning.
• Develop and embed process excellence and consistency across eTMFs management.
• Establish industry standard processes for eTMF by incorporating the applicable changes to the TMF reference model.
• Accountable to ensure consistency in eTMF management at all stages (eTMF set-up, maintenance, QC/ QR and query management, final reconciliation, closure, migration and archiving).
• Provide TMF support for both inspection and audit activities for internal and external hosted audits. This includes working directly with Agency Inspectors (FDA, EMA, PMDA, MHRA, etc) or auditors; assist with retrieving documents, speaking to the TMF process and assisting with resolving potential issues identified.
Education
• BS/BA in Life Sciences or similar discipline
Experience Required
• Minimum 5 years of experience in similar position in Pharmaceutical or CRO industry and in R&D environment
• Demonstrated individual and team leadership skillsExtensive experience managing eTMF including set-up, maintenance, QC/ QR and query management, final reconciliation, migration and archiving.
• Experience with various eTMF systems; must have experience with Phlexglobal eTMF
• Strong knowledge of the TMF reference model
• Experience managing paper TMF is preferred
• Previous experience with internal/ external audits and inspection is an asset
• Knowledge of ICH GCP and applicable regulations
• Strong knowledge of Good Document Practice requirements & ALCOAC+ standards
• Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global), and government agencies
• Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities and aggressive deadlines
• Proficient in MS Office (Word, Excel, Outlook, Project and PowerPoint), Adobe and ISI Toolbox
Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
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Nearest Major Market: Boston