Clinical, Associate Director

Company: Jobleads
Location: Canton
Posted on: June 1, 2021

Job Description:

Share this job as a link in your status update to LinkedIn. Job Title Clinical, Associate Director Job Description We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others. Empowering Healing. Organogenesis corporate headquarters is located in Canton, Massachusetts, and we have an additional site in Norwood, Massachusetts. Our Canton location is the manufacturing site for PuraPly AM (which heals acute and chronic wounds), and Apligraf (for the treatment of surgical wounds). Our Norwood location manufactures ReNu (offering regenerative and anti-inflammatory properties to create an environment that reduces pain) and NuCel (which provides an enhanced environment for tissue growth, repair and healing). Canton is also the location for Customer Service, Reimbursement and other corporate teams, supporting our full range of products. The Associate Director will provide leadership, project management, and program oversight to plan and conduct one or more high quality clinical trials concurrently in accordance with CFR and ICH GCP regulations in support of providing safety and effectiveness data for the company's advance wound care program. The Associate Director will manage all operational aspects of clinical trials as assigned. Open effective, and proactive communication of the clinical development activities is critical for success in this role. Must have an excellent understanding of the drug/device development process in order to effectively manage internal and external cross-functional teams. Must have strong work ethics and be able to work independently and productively. Must be willing to travel up to 25%. Responsibilities will include: Responsible and accountable for the conduct of clinical trials. Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality. Coordination/execution of all operational aspects of clinical studies (including identification and management of sites, CROs and vendors Work collaboratively with cross functional internal and external teams including regulatory agencies, medical consultants and biostatistics Identify, qualify, audit, and manage all external vendors, including CROs. Take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company's business objectives. Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR regulations, ICH GCP guidance, and study protocol. Identify any gaps in company/CRO SOPs and develop internal SOPs as needed. Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators and field team on developing robust study protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Performs site monitoring with clinical team, as needed. Facilitates all start-up activities including but not limited to investigational site contracts, investigational site, and IRB/ethics committee submissions. Facilitate confidentiality agreements, negotiate study agreements and budgets with sites and external vendors. Responsible for writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, , close-out plans, and CSRs. Assist with the development of presentations, handouts, and coordination ofInvestigator Meetings. Drive site selection and patient recruitment programs that deliver enrollment targets. Responsible for ensuring the trial is "audit ready" at all times. Work with appropriate team members to ensure that all TMF-related documentation is current, on-file at respective site, CRO, and sponsor locations throughout trial conduct. Notify and prepare team for regulatory agency audit and address any auditobservations appropriately and in a timely manner. Performs oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported. Provides regular updates to management team, vendors and contract staff concerning status and progress of the trial. Manages each project within agreed upon timelines. Proactively monitors and reports trial progress and performance, timelines, and financial metrics on an ongoing basis to management team, including current status of study milestones and forecast budgetary requirements based on scope of work. Job Requirements BS/BA degree required in science/health-related field. A Master's degree is preferred. The candidate should have a minimum of 10 years of clinical research and/orclinical project management experience in domestic and/or international clinical trials. Excellent working knowledge of ICH GCP guidelines, CFR, GDPR and HIPAA Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward. Excellent written and oral communication and presentation skills The ability to manage multiple priorities, while maintaining attention to detail is critical. Experience operating effectively within a matrixed environment, specifically in a healthcare/pharmaceutical start-up setting. Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities. Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels. Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IWRS/EDC platforms). Physical Required Job Type Full-time Location

Keywords: Jobleads, Canton , Clinical, Associate Director, Other , Canton, Michigan