The Opportunity : Senior Clinical Trial ManagerThis is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.
The Senior Clinical Trial Manager (Sr. CTM) provides oversight of clinical trials according to all applicable regulations and guidance, ICH / GCP and SOPs.
The Sr. CTM leads the cross-functional clinical trial team and partners with internal and external team members / key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to : CRO and vendor selection, contracting and management;
inspecting and monitoring CROs; clinical trial protocols and patient recruitment; system design and activation; risk mitigation plans and assessments;
reporting and metrics; and safety events and reporting.What you’ll dive into : Leads the clinical operations team (CRAs and CTAs) and cross-functional clinical trial team in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelinesResponsible for clinical trial material (CTM) label review and approval and assisting with CTM forecastingProactively identifies and resolves operational issues / processes to ensure achievement of study milestones, data quality and data integrity;
escalates study-related issues appropriately in a timely mannerObtain and relay key study issues, status updates and other study information to the clinical trial team and managementManages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper managementInteracts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product) and clinical vendors (e.
g., central laboratory, CROs), as needed, to support clinical trial activitiesProvides input on the development of eCRF designParticipates in IRT, EDC and ePRO user acceptance testingParticipates in data cleaning, listing, and report output reviewsDevelops, reviews, and approves study-related manuals, plans, specifications, charters, newsletters, and materialsParticipates in protocol deviation listing reviews and meetingsResponsible for oversight of study budget, investigator and vendor contracts, budgets and paymentsParticipates in protocol, table, figure, data listings and clinical study report reviewsProvides input / reviews DSUR, PSUR and regulatory annual and periodical reportsDevelops presentations for clinical sites, team and investigator meetingsProvides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit readyMay be responsible for a defined region, vendor or process across a programMay have functional reporting responsibilitiesPerforms other work-related duties as assigned or requiredDemonstrates interpersonal versatility, able to simultaneously serve as an individual contributor and a leaderThinks strategically and tacticallyAbility to manage trial(s) independently with minimal oversightLeads through influence with ability to manage and mentor internal personnel and external resourcesParticipates in the identification and selection process for CROs and vendorsProvides input on protocol design and statistical analysis plan (SAP)Mentors less experienced Clinical Trial Managers and Clinical Operations team members;
assists with team developmentQualifications : Bachelor’s degree8+ years of relevant and progressive clinical trial management experienceExperience in full-cycle drug developmentStrong understanding of clinical trials processes, protocols and medical terminologyStrong experience utilizing CTMS, EDC, TMS and related softwarePrior experience in management and monitoring of CRO and investigative sitesStrong experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget managementBroad knowledge of ICH, GCP, IRB / IEC and local regulatory authority drug research & development regulationsAdvanced experience with bio-samples, storage of 3rd party dataMotivated to work in a fast-paced, high accountability environmentExperience in Arena’s focused therapeutic areas, preferredTravel up to 25%Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures.
If you need assistance due to a disability, you may contact us at jobs arenapharm.com.