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(Remote) Senior Clinical Program Manager

Company: Real Life Sciences
Location: Somerville
Posted on: January 16, 2022

Job Description:

Senior Clinical Program ManagerJob SummaryThe Senior Clinical Program Manager is responsible for management of clinical studies managed to ensure accurate and complete data and compliance with protocol(s) and Federal Regulations, ICH, GCP, and local requirements. This position oversees clinical trial operations internally, and as performed by a CRO, vendor, and external consultants. The client is working on a natural history study.Essential Job Functions And DutiesAuthor or prepare clinical protocols, informed consent forms, clinical study reports, regulatory documents (e.g., IND, BLA, etc.), and other clinical documents by coordinating input from internal team members and external sourcesContribute to the development of abstracts, presentations and manuscriptsDevelop and manage study timelines and budgets in collaboration with cross functional teams; mitigate challenges that occurProvide leadership, subject matter and therapeutic expertise for successful management of international and country specific clinical trialsEnsure compliance with SOPs and guidelines, Good Clinical Practice (GCP), International Council on Harmonisation (ICH) guidelines and regulatory requirements for clinical trial managementLead multidisciplinary Project Teams to ensure trial deliverables are met according to timelines, budget, quality standards and operational best practicesIndependently manage all components of clinical studies to strategically implement clinical development program(s)Oversee recruitment and retention of study subjectsCollaborate with strategic sourcing on the development of RFPs and participate in selection of CROs/vendorsManage and oversee vendors for clinical studiesPlan and participate in conduct of Investigator MeetingsProvide protocol and trial specific training at Investigator Meetings and Site Initiation VisitsInitiate, participate in and/or lead departmental or interdepartmental strategic initiativesEstablish strong partnerships with external investigators and collaborators and communicate study-related information to investigators and study staffEnsure ongoing activities (e.g., sponsor updates, drug shipments, publications, milestone payments, etc.) for efficient study management and clinical trial executionProactively identify potential operational challenges (e.g., internally/CRO/vendor/investigator) and provide resolution plans and implement solutions to achieve project goalsInitiate, author, and/or contribute to SOP development, implementation and trainingRecruit, hire, mentor, manage, and develop junior staff members (e.g., Clinical Program Manager, Clinical Scientist (CS), CTA), as assignedLead multidisciplinary Study Team to ensure trial deliverables are met according to timelines, budget, quality standards and operational best practices.Oversee the review of data listings and preparation of interim/final clinical study reportsDevelop tools and processes that increase measured efficiencies of a projectSupport inspection readiness and audits as requiredParticipate in vendor and site audits as neededOther tasks may be assigned based on skill sets and business needMinimum RequirementsRequired education: Bachelor's, Master's degree preferredNatural History experience prefferedAt least 10 years of clinical trial management, clinical operations or clinical research and development experience including site monitoringCertified in clinical research preferredExperience in global protocol development, study implementation, study management, monitoring, and study report preparation is requiredTherapeutic Area(s) experience preferred: Infectious Disease, Vaccines, Oncology, or Women's Health.Experience with vaccines highly preferredMedical device experience a plusMS Office Suite proficiency (Word, Outlook)Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplinesAttention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplinesThorough understanding of FDA regulations, GCP/ICH guidelines, and ISO requirements is required.EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.To find out more about Real please visit

Keywords: Real Life Sciences, Somerville , (Remote) Senior Clinical Program Manager, Healthcare , Somerville, Massachusetts

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