Senior Clinical Trial Manager, 9503
Posted on: September 23, 2018
Job Scope & Purpose: Our client, a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases, is adding to their experienced clinical operations team and seeking two strong clinical trial management professionals due to an increase of new, innovative, gene therapy trials in a diverse pipeline. The Senior/Clinical Trial Manager (CTM) is responsible for the planning, implementation, and conduct of one region, or less complex, clinical trials in Phase I-IV. The CTM is accountable for the day-to-day operations of multiple clinical trials including but not limited to study start-up, conduct and close out activities. The individual will manage the clinical project team members to ensure timely completion of projects; oversee project timeline development and maintenance. Primary Job Responsibilities: Clinical Trial Management ---Manage CROs, vendors, and consultants that are involved with the clinical trial and program. ---Serve as the clinical point person managing protocol execution. ---Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines. ---Participate in program strategy meetings, ad hoc clinical operations' initiatives and programs as assigned. ---Ensure study staff is appropriately trained on relevant guidelines, regulations and SOP's. ---Ensure trial adherence to ICH/GCP/Federal and local regulations and company-specific SOPs ---Assist in preparation of clinical documentation for IND updates as well as NDA submission and other regulatory authority submissions as appropriate. ---Review and provide input for reports and clinical documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates. ---Review and approve clinical monitoring visit reports and ensure that all outstanding follow-up items are closed out in a timely manner. ---Responsible for communication and escalation of study related issues as required. ---Responsible for forecasting of Investigational Medicinal Product and clinical trial related supplies. ---Conduct periodic reviews of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed. ---Participate and respond to Quality Assurance and/or regulatory authority inspection audits. Fiscal and Contracts Management ---In conjunction with the legal group, facilitate the development of clinical trial agreements and other relevant documents. ---Review and approve site budgets, manage clinical trial budgets, provide financial reporting and projections. ---Participate in the creation of scope of work, budgets, vendor performance, and issue resolution. ---Reconcile and report vendor and site payments, and change orders ensuring accuracy and timely delivery to finance. Cross-Functional Mentoring and Leadership ---Work cross-functionally to ensure clinical program timelines and goals are met. ---Provide study-specific mentoring and line management for junior team members, as appropriate. ---Participate in operational improvement initiatives (e.g.SOP development, training, etc.) ---Assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports. Primary Job Requirements: ---Bachelor's degree in health sciences or related field. ---Minimum of 5+ years' experience in clinical research with at least 2 years' experience in Project Management of complex studies with a focus on pediatric rare diseases preferred. ---Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required. ---Experience in management of CROs, vendors, and consultants ---Experience developing trial plans including site monitoring and risk mitigation strategies, trial budgets, site selection, and clinical supply management. ---Proficient written and verbal communication skills. ---Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills. ---Therapeutic or medical knowledge preferred. ---Strong computer skills including knowledge of Excel, Word, PowerPoint, and Outlook. ---Position may require some travel. About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member.We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information.Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals.We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT--- Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us at or .
Keywords: stratacuity, Methuen , Senior Clinical Trial Manager, 9503, Healthcare , Cambridge, Massachusetts
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