Senior Clinical Trial Manager

Arena Pharmaceuticals

Zug, Switzerland

vor 5 Tg.

The Opportunity : Senior Clinical Trial Manager

This 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 guidelines

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

Proactively 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 manner

Obtain and relay key study issues, status updates and other study information to the clinical trial team and management

Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management

Interacts 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

Provides input on the development of eCRF design

Participates in IRT, EDC and ePRO user acceptance testing

Participates in data cleaning, listing, and report output reviews

Develops, reviews, and approves study-related manuals, plans, specifications, charters, newsletters, and materials

Participates in protocol deviation listing reviews and meetings

Responsible for oversight of study budget, investigator and vendor contracts, budgets and payments

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

Provides input / reviews DSUR, PSUR and regulatory annual and periodical reports

Develops presentations for clinical sites, team and investigator meetings

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

May be responsible for a defined region, vendor or process across a program

May have functional reporting responsibilities

Performs other work-related duties as assigned or required

Demonstrates interpersonal versatility, able to simultaneously serve as an individual contributor and a leader

Thinks strategically and tactically

Ability to manage trial(s) independently with minimal oversight

Leads through influence with ability to manage and mentor internal personnel and external resources

Participates in the identification and selection process for CROs and vendors

Provides input on protocol design and statistical analysis plan (SAP)

Mentors less experienced Clinical Trial Managers and Clinical Operations team members; assists with team development

Qualifications :

Bachelor’s degree

8+ years of relevant and progressive clinical trial management experience

Experience in full-cycle drug development

Strong understanding of clinical trials processes, protocols and medical terminology

Strong experience utilizing CTMS, EDC, TMS and related software

Prior experience in management and monitoring of CRO and investigative sites

Strong 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

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

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

Experience in Arena’s focused therapeutic areas, preferred

Travel up to 25%

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