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kps life · 1 week ago

Clinical Project Manager - Oncology

Radnor, PA

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

KPS Life is a biotechnology company specializing in clinical research, and they are seeking a Senior Clinical Project Manager to oversee large complex clinical studies. The role involves managing project documentation, training staff, maintaining compliance with regulatory requirements, and ensuring successful execution of clinical programs.

Health CareMedicalWellness

Responsibilities

Ensure successful execution and oversight of assigned programs ensuring the program deliverables and milestones are met with quality and within budget

Provide oversight and accountability of all third-party vendors assigned to a program or assigned protocol

Play an active part in CRO selection and review of RFP’s when required, ensuring the appropriate CRO is identified and properly vetted. Work with internal and external teams as required, ensuring the company FIP/M development projects are initiated and managed in line with company strategy and key clinical and regulatory milestones

Review, negotiate and approve any required change orders

Develop and manage the overall study budget, forecast spend, and ensure study costs stay within predicted spend and identify and communicate study issues that will impact budget, resources and timelines

Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures. Ensuring knowledge is kept up to date by reading SOP’s and maintaining awareness of GCP guidelines

Ensure program meets all GCP/ICH Guidelines and is Inspection Ready

Assist and contribute in authoring company study protocols, protocol amendments and other related study documents, as required, from the initial scientific discussion

Review and approve CRFs, IRTs and other relevant specifications from a clinical perspective, ensuring the successful support of data collection

Routinely review study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies. This includes reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals

Develop and operationalize biomarker strategies, when required

Establish, monitor and maintain procedures as required to ensure regulatory compliance of protocol activities

Contribute to IND development and other regulatory documents including but not limited to briefing books, regulatory submissions and responses

Contribute high level input to regulatory documents such as Investigator’s Brochures and development safety update reports (DSUR); with the ability to create and/or update these where necessary and asking for input where appropriate

Provide expert and collegiate support to other members of the drug development team to ensure full success of the company’s portfolio and regulatory milestones

Assist in SOP and working instruction development, review and approval within the company

If supporting a Phase FIH/P study, work closely with internal scientific, translational and clinical colleagues to deliver fit for purpose Phase I/Ib clinical studies in line with related regulatory requirements and internal quality processes

Contribute as required to the scientific, intellectual property, and business development aspects of the company’s activities in order to help fully realize their potential, such as; biomarkers, trial designs, FIH study designs/operational implementation and BLA/MAA filing support

Qualification

Clinical Project ManagementOncology ExperienceRegulatory ComplianceVendor OversightBudget ManagementClinical Study ConductMicrosoft Office SuiteProcess ImprovementTeam LeadershipCommunication Skills

Required

BA / BS. or higher in science related field (biological science, pharmacy or other health related discipline)

At least 8 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research organization, including majority of time in clinical study/project management

Experience must include global/international studies or programs

Experience in infectious disease and/or oncology is highly desired

Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint) and ability to develop proficiency in relevant IRT and EDC systems and programs

Experience with Vendor oversight

Experience with all aspects of the conduct of a clinical study including start-up through close out

Familiarity with global regulatory regulations and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, GDP and ICH GCP. Awareness of local country requirements is also required