Associate Director, Training And Process Oversight

Arena Pharmaceuticals San Diego , CA 92140

Posted 3 months ago

Join our Clinical Operations Team at Arena! Help us improve patient lives by executing clinical trials to deliver transformational medicines. We are diverse and growing, and dedicated to building a top notch, high-performing team with the addition of people like you. Arena offers a unique opportunity to work on a diverse pipeline of products being developed to fulfill unmet patient needs across various indications. We value collaboration, positive "can do" attitude and commitment to driving results. Join our team and together we can make a difference!

The Associate Director of Training and Process Oversight is responsible and accountable for the conduct of clinical trials according to all applicable regulations and guidance, ICH/GCP and SOPs. The AD will typically manage an indication or specific elements within a clinical development program (e.g., UC or CD within an IBD program). The AD 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.

What you'll dive into

  • Leads the clinical operations team (CTMs, CRAs and CTAs) and cross-functional clinical trial team in the planning, execution and completion of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines

  • Contributes expertise in all operational activities relating to the execution of clinical trials

  • Supports program management with supportable and clear timeline projections and re-projections

  • Interacts and develops relationships with key opinion leaders, potential/selected investigators, and other key experts through attendance at therapeutic conferences and study investigator meetings

  • Contributes to the development of team and resourcing planning

  • Participates in the selection and oversight of Contract Research Organizations (CROs) and vendors

  • Ensures completion of all study-related materials and systems according to timelines and standards

  • Provides input on the development of eCRF design

  • Responsible for clinical trial material (CTM) label review and approval and assisting with CTM forecasting

  • Responsible for oversight of study budget, investigator and vendor contracts, budgets and payments; completes accruals on a regular basis

  • Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues, risks and mitigation plans to management in a timely manner

  • Oversees recruitment plans and activities to meet study enrollment goals and timelines

  • Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready

  • Facilitates GCP QA compliance and contributes to quality variances investigations and audits

  • Understanding of study drug mechanism, prior clinical data and study specific data integration flow well enough to be able to answer basic questions accurately and find answers quickly

  • Develops and leads presentations and trainings for clinical sites, team and investigator meetings

  • Interacts with and participates in strategy discussions 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 activities

  • Participates in protocol deviation listing reviews and meetings

  • Participates in protocol, table, figure, data listings and clinical study report reviews

  • May have functional reporting responsibilities or indirect reports (e.g., study team members)

  • Assists with clinical operations process development, innovative problem solving and training initiatives

What we expect

  • Bachelor's degree

  • 8+ years of relevant and progressive clinical trial management experience

  • Experience in full-cycle drug development

  • Advanced understanding of clinical trials processes, protocols and medical terminology

  • Advanced experience utilizing CTMS, EDC, TMS and related software

  • Prior experience in management and monitoring of CRO and investigative sites

  • Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management

  • Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations

  • Strong experience with bio-samples, storage of 3rd party data

  • Motivated to work in a fast-paced, high accountability environment

  • Travel up to 25%

What you'll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives

  • Opportunities to learn and contribute creative solutions

  • Comprehensive health insurance

  • Matching 401k retirement plan

  • Paid time off and holidays

  • Company celebrations

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.


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Associate Director, Training And Process Oversight

Arena Pharmaceuticals