Clinical Project Manager / Sr. Clinical Project Manager
Job Title: Clinical Project Manager
Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.
Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies. Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.
- As clinical study lead, manage study execution, including management and oversight CROs, vendors and consultants that are involved with the clinical trial.
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
- Ensures risks are proactively identified, managed, and mitigation strategies implemented
- Ensure trial adherence to ICH-GCP, Federal and local regulations and company specific SOPs.
- Oversees investigator recruitment/ selection
- Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs.
- Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs.
- Contribute to preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status updates.
- Maintains primary responsibility for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, safety plans, project management plans, communication plans, and quality plans.
- Review and provide input on clinical monitoring visit reports and ensure that all outstanding follow-up items are closed out in a timely manner.
- Tracks study progress ensuring timely data collection, monitoring and, in collaboration with data management, internal listings reviews
- Ensure Investigational Medicinal Product and clinical trial supplies are forecast and tracked, interacting with appropriate functional areas as needed to resolve issues.
- Ensure that the Trial Master File (TMF) is set up and maintained throughout the trial in compliance with ICH/GCP and company SOPs, including conducting periodic reviews to ensure all appropriate documents are filed.
- Assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports.
- Participate and respond to Quality Assurance and/or regulatory authority inspection audits.
- Responsible for ongoing study communication and escalation of study related issues as required.
- In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents.
- Contribute to request, creation and review of scope of work and budgets; participate in vendor performance management and issue resolution.
- Manage clinical trial budget, providing ongoing financial reporting and projections to finance.
- Reconcile and report vendor and site invoices, payments and change orders, ensuring accuracy and timely delivery to finance.
- Work cross-functionally to ensure clinical program timelines and goals are met.
- Participate in site visits, evaluating CROs/contract monitors through co-monitoring visits and/or site audits
- Provide study-specific mentoring and line management for junior team members, as appropriate.
- Participate in operational improvement initiatives (e.g. SOP development, training, etc.)
Education & 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 study management.
- Experience in management of CROs, vendors and consultants.
- Documented training, knowledge and application of current FDA Regulations, ICH-GCP guidelines in clinical trials required.
- Experience developing trial plans including site monitoring, 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.
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.