Senior Clinical Trial Manager
Clinical Operations
Posted on 2/28/2024
Coherus BioSciences

201-500 employees

Biologic platform therapeutics manufacturer
Company Overview
Coherus' mission is to expand patient access to important, cost-effective medicines and deliver significant savings to the U.S. healthcare system. The company has created the leading biologics platform company solely focused on delivering high-quality biosimilar therapeutics that will expand patient access to life-changing medicines in regulated markets worldwide.
Biotechnology

Company Stage

N/A

Total Funding

$1.2B

Founded

2010

Headquarters

Redwood City, California

Growth & Insights
Headcount

6 month growth

0%

1 year growth

-9%

2 year growth

0%
Locations
San Carlos, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Word/Pages/Docs
PowerPoint/Keynote/Slides
CategoriesNew
Operations & Logistics
Requirements
  • BS in life sciences or equivalent work experience
  • 10+ years of biotech/pharmaceutical clinical operations experience with at least 7 in a clinical trial management role
  • Experience in managing the execution of complex and/or global clinical trials, particularly in oncology-related therapeutic areas
  • Strong 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, and developing study documentation
  • Ability to travel domestically and internationally
Responsibilities
  • Collaborate with other Coherus functional areas and consultants to coordinate assigned clinical study/program
  • Act as primary liaison to CROs and vendors for assigned clinical study/programs
  • Facilitate study start up with CROs and clinical sites as necessary
  • Organize and run assigned clinical study team meetings and teleconferences
  • Manage study logistics and monitoring activities to ensure milestones and deliverables are achieved
  • Track and report clinical trial information and progress
  • Conduct clinical site, CRO, and/or vendor monitoring visits
  • Ensure adherence to all documentation requirements and process at the CRO(s), all other vendors and within Coherus
  • Assist in the development of clinical project timelines to meet critical company milestones
  • Write or contribute to the development of clinical documents
  • Coordinate the RFP process, review vendor proposals, and negotiate budgets for assigned clinical study/program
  • Assess feasibility for assigned clinical studies and contribute to the investigator/site selection process
  • Assist in the development, forecasting, monitoring, and reporting of assigned clinical study/program budgets
  • Ensure the clinical studies are conducted in compliance with regulations and internal Standard Operating Procedures
  • Contribute to the writing and implementation of Standard Operating Procedures (SOPs), standard forms and study-specific guidelines to support clinical operations
  • May manage or mentor other clinical operations staff
  • Perform other related tasks as requested
Desired Qualifications
  • Ability to motivate a team to work effectively in a changing and fast-paced environment
  • Demonstrated computer skills using MS Office Suite (MS Word, Excel, PowerPoint, MS Outlook, and MS Project) software