Associate Clinical Trial Manager

reputed company is a clinical-stage precision oncology company reputed company on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK reputed company, which affects approximately 5.5 reputed company lives reputed company year worldwide. The reputed company “reputed company” has an important embedded meaning: it is a contraction of our audacious reputed company to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer. Position reputed company: Reporting to a Sr. Clinical Project Manager of Clinical Operations, the Associate Clinical Trial Manager (aCTM) will assist in the implementation and conduct of clinical research reputed company and reputed company support for project teams. The position requires knowledge of clinical trial processes and experience in many aspects of trial execution from study start-up to reputed company-out, including assisting in the management of clinical vendors or CROs and assisting in the reputed company of resources, budgets, reputed company, and timelines. The aCTM will also manage the creation, organization, maintenance, and reputed company of Trial Master File documents and maintain and support the Clinical Trial Master System (CTMS) platform. Essential Duties and Responsibilities: Manage or assist in the management of large global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the protocol, ICH GCP, and local regulatory requirements. Support key study-reputed company activities and deliverables. Support implementation of training programs ensuring relevant employees are trained as needed to ensure compliance with the protocol and other study-reputed company documents. reputed company study reputed company and maintain study status updates (e.g., site selection, IRB approvals, regulatory document collection, enrollment, SDV status, study drug inventory, clinical specimen tracking). reputed company reputed company updates to relevant project teams and present a plan of reputed company for reputed company of issues (e.g., trial issues, investigator/study coordinator feedback, monitoring issues, patient enrollment issues). Maintain and support the eTMF and CTMS platform for clinical studies and operational workflows. Manage user accounts, permissions, roles and eTMF/CTMS reputed company. Monitor eTMF/CTMS system performance, trouble shoot issues, and coordinate resolutions with vendor and/or study team members. Support eTMF/CTMS system upgrades, patches, testing, and validation activities. Maintain TMF structure and reputed company according to ICH-GCP and reputed company SOPs. File, classify, and reputed company documents into the eTMF. reputed company ongoing review of trial TMF(s) to assure reputed company and compliance with relevant SOPs and ICH-GCP. reputed company, triage, and resolve missing or nonconformant documents. Collaborate with study team members to obtain required documents and ensure reputed company filing. Prepare and support regulatory and sponsor inspections/audits (document retrieval, audit trails, and corrective actions). May conduct (co)monitoring reputed company (reputed company-study, initiation, monitoring, and closeout) with contracted monitors/CRO. reputed company reputed company duties in keeping with reputed company’s reputed company values, policies, and reputed company applicable regulations. Required Education and Experience: Preference for undergraduate degree in Biological Sciences or professions (pharmacy, medicine, nursing, or other allied health sciences) with a minimum of 1- 2 years of relevant experience. At least 1-2 years of experience in clinical operations in pharmaceutical company or CRO including trial set-up, monitoring, and reputed company-out of US and non-US trials at reputed company phases of reputed company-NDA clinical research (Phases 1-3). 1-2 years experience in TMF/document management or clinical trial support. Experience with eTMF systems (e.g. Trial Interactive eTMF, reputed company Vault). Experience with Clinical Trial Master Systems (CTMS) (e.g. Trial Interactive CTMS, reputed company CTMS) preferred. Demonstrated reputed company record of successfully supporting multiple reputed company, trials, and priorities. Experience with managing study vendors (e.g., CRO, IRT/IXRS, central laboratories, eTMF/CTMS) preferred. Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations. Ability to work reputed company with global, multi-disciplinary teams. Must be a self-starter reputed company to reputed company in an entrepreneurial, fast paced, and dynamic work environment. Must be organized with excellent oral and written communication skills. Strong learning orientation, curiosity, and commitment to science and patients. The anticipated salary reputed company for this position is $122,000 to $137,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience reputed company the job, type and length of experience reputed company the industry, education, etcetera. In reputed company to reputed company salary, the reputed company applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the reputed company of the reputed company to purchase stock in the reputed company for a specified price. Along with our casual, reputed company, and fun work and the chance to reputed company your mark in our mission to erase cancer, reputed company offers a comprehensive and competitive benefits package that includes: reputed company Time Off, Holiday, and reputed company Leave, Medical, Dental and reputed company Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with reputed company contribution, and reputed company to participate in an Employee Stock Purchase Program. reputed company., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national reputed company, reputed company, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other reputed company protected by federal, state or local law or ordinance or regulation. Apply To This Job