Senior Clinical Trial Manager

Senior Clinical Trial ManagerWatertown, Massachusetts, United StatesWe are seeking a Senior Clinical Trial Manager with relevant Clinical Operations experience to join our growing Clinical Development group who will be responsible for providing trial management support for our oncology programs. This role will report to the VP, Clinical Operations. Job responsibilities include, but are not limited to, preparation of study related materials, enrollment tracking and reporting, relationship management with study sites and vendors (in particular CROs), supervision of study-related activities, identification of project risks and contingency planning.Responsibilities:Clinical Operations point of contact for execution of clinical studies in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work InstructionsManage clinical CRO(s) and other study vendors from initial contact through to final study deliverables.Lead external (CRO) trial management team, to ensure conduct in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPsEnsure coordination of the CRO activities are timely, coordinated and complete, including but not limited to clinical monitoring, data management, medical monitoring, medical writing, statistics and safety/pharmacovigilance.Provide operational input into study documents including clinical protocol, informed consent, CRFs, any and all CRO study documents/study plans.Develop, manage, and maintain study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholdersProactively identify potential study risks and develop/implement actions to avoid or mitigate potential risksDevelop/coordinate study training and associated materials for study team, investigational sites, and vendors in collaboration with medical and scientific colleagues both internally and externallyAttend (in person and virtual) study site visits, such as pre-study selection visits, site initiation visits, and PI engagement meetingsResponsible for supporting the management, oversight and maintenance of the Trial Master File (TMF) held by the CROQualifications:Bachelor's degree, or equivalent, in a biomedical, life science or related field of study5-8+ years of trial management experience as primary Clinical Trial Manager (or equivalent) within Pharma, Biotech or CRO; Oncology experience required.Strong understanding of global regulatory and compliance requirements for clinical researchStrategic understanding of how outcomes, budgets, and timelines are impacted by decisions.Outstanding teamwork, organizational, interpersonal, and problem-solving skillsEffective communicator both verbally and in written formAbility to influence and collaborate well with colleagues and partners in a fast-paced growing development companyPlease note: This role is based out of our Watertown, MA office and is not a remote role.This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown, MA is $153,000 to $197,600. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, education, and other factors.Recruitment fraud statementPlease be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.We do not conduct interviews through RingCentral, Skype or Telegram.Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.You can find more information about job scams at consumer.ftc.gov/articles/job-scams.To report job scams, head to ReportFraud.ftc.gov.