Senior Clinical Trial Manager

Summit Therapeutics, Inc.; Menlo Park (CA); On-site; USD 153,000 - 180,000; Full time

Job summary

An established industry player is seeking a highly autonomous Clinical Trial Manager to oversee global studies. This role involves managing clinical trial operations from start to finish, ensuring quality and compliance with regulatory requirements. The ideal candidate will have extensive experience in clinical project management, particularly in oncology, and a proven track record of building strong relationships with key stakeholders. Join a dynamic team where your expertise will drive the success of innovative clinical trials and contribute to groundbreaking advancements in healthcare.

Benefits

Relocation Support

Qualifications

• 8+ years of clinical project management experience in international trials.
• Solid understanding of drug development process and ICH guidelines.

Responsibilities

• Oversee study scope, quality, timelines, and budget with internal leads.
• Develop and manage clinical trial documents and ensure compliance.

Skills

Clinical Project Management

Budget Forecasting

Patient Enrollment Strategies

Interpersonal Skills

Problem Solving

Time Management

Communication Skills

Critical Thinking

Education

Bachelor’s degree in Life Science

Equivalent in Nursing/Pharmacy

Tools

MS Office Suite

Electronic Document Management Systems

Job description

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• Relocation support will be considered for this role
  
  

THIS POSITION WILL BE ON-SITE IN: San Francisco Bay Area

• Relocation support will be considered for this role
  
  

Overview Of Role

Highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.

Role And Responsibilities

• Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met
• Initiates and builds solid professional relationships with key opinion leaders and clinical site staff
• Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time
• Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
• Proactive identification and management of study related risks
• Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
• Responsible for reviewing and managing study related plans, processes including
• Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring
• Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met
• Reviews and approves essential document packages to enable timely site activations
• Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
• Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
• Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
• Perform periodic QC of the TMF
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
• Ensures the study is “inspection ready” always
• Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project
• All other duties as assigned.
  
  

Experience, Education And Specialized Knowledge And Skills

• Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
• A minimum of 8+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
• Prior phase II and III experience required
• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Experience with budget forecasting and management
• Experience with clinical studies in oncology
• Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
• Proven proficiency in overseeing large complex studies being managed in house and by a CRO
• Demonstrated ability to lead teams and work in a fast-paced team environment
• Experienced and enjoys building relationships with KOLs and site personnel
• Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues
• Demonstrated ability to build and deliver on patient enrollment strategies
• Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
• Demonstrated ability to comprehend complex scientific concepts and data
• Proficient in reviewing and assessing clinical data
• Possesses excellent planning, time management & coordination skills
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• Experience in working in a small organization
• Excellent written and oral communication skills
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
• Strong computer and database skills
• Attention to detail, accuracy and confidentiality
• Clear and concise oral and written communication skills
• Excellent organizational skills
• Critical thinking, problem solving, ability to work independently.
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
• Communicate effectively and articulate complex ideas in an easily understandable way
• Prioritize conflicting demands.
• Work in a fast-paced, demanding and collaborative environment
  
  

The pay range for this role is $153,000 to $180,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Strategy/Planning and Information Technology

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