Manager Regional Clinical Trials – GENZYME CORPORATION – Swiftwater, PA, USA
Manager Regional Clinical Trials-00406738-60538JC Description Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases.The company’s heritage, to create vaccines that protect life, dates back more than a century. Every day, the company invests more than one million Euros in research and development. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs.
Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines,innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. The Clinical Trial Manager (CTM) is responsible for overseeing and managing a clinical project assigned within the Study Management Platform (SML). The CTM represents the SML platform within the Clinical teams and is responsible to manage and oversee the field sources (Contract Research Organization (CRO) Clinical Research Associates (CRAs) and independent contractors) in charge of the field monitoring activities, ensuring quality of the deliverables and the respect of deadlines for the trials managed. Moreover, the senior CTM may be assigned study and/or project coordination with mentoring on project related questions and may coordinate the SML team in complex programs where several CTMs are involved.
Pre Trial Activities Conduct study feasibility assessments Prepare study specifications and Work Order Task List (WOTL) for CRO selection Participate in review of monitoring proposals and CRO selection including validation of resources (Clinical Monitoring Manager (CMM) to review) Coordinate with the Procurement department on identification and selection of vendors as needed Review study documents, such as concept protocol/protocol and Case Report Forms (CRFs) /Informed Consent Form (ICF) Create and ensure review and approval of study documents (i.e, Monitoring plans, operating guidelines, etc) Oversee and/or perform site identification/selection including pretrial visits Study setup in the Clinical Trial Management System Manage Ethics Committee (EC) /IRB submission, follow up and approval. Initiate and follow up with translation requests Participate in the preparation and conduct of investigator meetings (assess on a trial to trial basis) Responsible to ensure the CRO is adequately trained to sustain their monitoring activities Accountable for the oversight of CRO, including Project Managers (PMs) and CRAs, to ensure timelines and quality are meeting Sanofi Pasteur expectations Oversee and manage activities related to investigational product Is the lead for peer review of study documents created or reviewed by SML platform May coordinate communication within SML team in complex programs where several CTMs are involved. During the Trial/ Study Management Assure investigator staff are trained in the conduct of the study Review and conduct Quality Control visits (QC visits) Follow up Corrective And Preventive Actions (CAPAs) in case of audits/ inspections CRO coordination and management including, effective communication with CRO Ability to setup an appropriate level oversight with CRO to detect any quality issues Follow up trial (review monitoring reports/ CRO representative reports): tracking of study progression, remote QC of Case Report Books (CRBs) / queries, Timely escalation of issues with CRO Review and send amended documents (protocols, ICFs etc) to sites, CROs and other vendors Manage IRB/EC (as applicable) submissions for amendments and required progress reports Ensure Trial Master File (TMF) updates & QC Ensure CTMS update Attend, participate and represent Study Management & Logistics in Clinical study team meetings and data review meetings Escalate issues to Clinical Team and/or management team appropriately May participate in Quality Assurance (QA) audits of trials and will follow up with in resolving audit actions Responsible for the management of biological samples, vaccines supplies and vaccine returns Assist monitors and/or conduct activities related to data review, site /investigator issues Oversee cold chain management Review Integrated Clinical Study Report (ICSR) Prepare applicable ICSR appendices Study coordination: May be the lead CTM for trial involving several CTMs Participate in CRO selection and validate resources accordingly Is the key contact of the study for the clinical team Is responsible for coordinating tasks among CTMs working on the same study for ensuring quality of deliverables and respect of timelines Project coordination: Check the consistency of documents across studies Is the mentor on project related questions Initiatives May be involved in update of Standard Operating Procedures (SOPs), identification of processes and efficiency improvement solution Qualifications Qualifications: Bachelor degree in a health related field (Biology, Life science, Pharmacy) Minimum of 5-8 years combined of experience in Good Clinical Practice (GCP) / International Conference on Harmonization (ICH), clinical development trial monitoring and project management Ability to work independently Ability to work on the multidisciplinary team Good interpersonal skills Good computer skills Excellent working knowledge of GCP/ICH standards Pasteur SA and its U.S. affiliates are Equal Opportunity and Affirmative Action All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.