Manager/Sr Manager, Clinical Operations - Job Ref ID: 2019-010

Viela Bio, Inc. Gaithersburg , MD 20877

Posted 2 months ago

Summary of Position

Viela Bio is looking for a talented and highly motivated Manager/Sr. Manager of Clinical Operations. This is a position requiring solid understanding of all aspects of industry sponsored clinical trials Phases 1/2. Individuals suited for this position are highly independent, organized, dedicated to their programs and motivated by achieving organizational goals. Viela Bio is a fast-paced bio-technology company created to push the boundaries of science and clinical development in pursuit of life changing treatments for patients with rare diseases.

Key Responsibilities

  • Provide matrix management of functional area representatives to cross-functional teams

  • Lead/oversee cross-functional CTTs for early phase studies

  • Define and manage accountabilities for all CTT members

  • Collaborate with cross-functional area heads to ensure proper resourcing for assigned trials

  • Support development of Protocol Concept Sheet (PCS) and Clinical Study Protocol (CSP)

  • Develop outsourcing specs for vendor requests for proposal and scope of work agreements

  • Manage selection of study vendors for assigned studies

  • Manage the vendor(s) throughout the life of assigned clinical trial

  • Provide input on investigational site selection in collaboration with Clinical Development and vendors

  • Review and refine Clinical Operations Plans/Vendor Oversight Plans

  • Provide oversight of monitoring activities through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs

  • Lead ongoing review of data to ensure quality and consistency

  • Participate in planning and conduct of investigator meetings and ad boards, etc.

  • Develops and manage program budget(s) and oversees site agreement/budget negotiation process, and manage program timelines

  • Oversee the submission of trial-related and essential documents to the Trial Master File

  • Identify and provide solutions to clinical trial issues or risks

  • Provide input into non-project related activities and development of procedures/SOPs

  • Facilitate training to clinical study teams on protocol specific topics

  • Participate as appropriate in internal and external audits

Desired Skills & Experience

  • Thorough understanding of country level regulations, ICH and GCP guidelines

  • Understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, CMC and regulatory affairs

  • Ability to lead a cross-functional team in a matrix environment

  • Strong interpersonal, verbal, written communication and negotiation skills

  • Proven complex problem solving and decision-making skills

  • Ability to travel occasionally (internationally and domestically)

  • Minimum of 6 years progressive experience in clinical operations including 3 years of clinical project management or equivalent

Education & Minimal Requirement

BS preferred

Please click HERE to submit your resume and cover letter. (Make sure to click Upload button on bottom left after your file selections)

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Manager/Sr Manager, Clinical Operations - Job Ref ID: 2019-010

Viela Bio, Inc.