Senior Clinical Trial Manager, Clinical Operations

August 29

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Coherus BioSciences

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We are in the business of extending life for patients.

biotechnology • biosimilars • Immuno-oncology

201 - 500

Description

• Work with the Coherus clinical team to manage execution of clinical studies. • Focus on complex Phase 1, global Phase 2-3 studies, and post marketing commitment studies. • Manage one or more clinical studies and/or manage a multi-national region. • Assist in management of CROs, clinical laboratories, and other vendors. • Collaborate with clinical development partners and other internal departments.

Requirements

• BS in life sciences, or equivalent work experience. • 10+ years of experience of biotech/pharmaceutical clinical operations experience with at least 7 in a clinical trial management role. • Must have experience in managing the execution of complex and/or global clinical trials, oncology-related therapeutic areas. • Strong experience in CRO and vendor management to support global clinical trials • Excellent knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management. • Demonstrated skills in writing/reviewing clinical study protocols, CRF designs, CSRs, regulatory documents (including IND/CTA, marketing application documents and annual/periodic updates) and developing study documentation. • Understanding of data management, statistics and medical writing processes for clinical development. • Ability to “roll up your sleeves” and individually contribute results to clinical operations and company-wide goals • Team-oriented with superior verbal and written communication and interpersonal skills, including a positive and professional attitude to tasks and projects. • Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment with little direct supervision. • Able to motivate a team to work effectively in a changing and fast-paced environment • Ability to travel domestically and internationally. Some travel will take place on/over weekends. • Demonstrated computer skills using MS Office Suite (MS Word, Excel, PowerPoint, MS Outlook, and MS Project) software. • Perform other related tasks as requested.

Benefits

• Equal employment opportunities • Prohibits unlawful discrimination and harassment