Sr CTM

POSITION SUMMARY

Seeking a highly motivated Senior Clinical Trial Manager (Sr. CTM) to be a part of our Clinical Operations team. This is a unique opportunity to join a growing company committed to converting biologics and peptides into life-changing small molecule medicines for everyone. The Sr. CTM will be responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites. The Sr. CTM will focus on the management and support of multinational, multicenter, Phase II studies and may assume responsibility for additional studies/indications as applicable. The Sr. CTM works closely with and supports the Clinical Development Operations team, receives assignments in the form of objectives, and will ensure deliverables are completed on time and within budget.

This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP, Country specific regulatory guidelines, company goals, and budgets. The Sr. CTM will be responsible for managing various project goals and supporting delivery of a quality study to meet current business needs and trends. This is a hybrid role that will require 3 days in the office (2 core days, 1 flex day).

ESSENTIAL DUITES AND RESPONSIBILITIES

• Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out).
• In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements).
• Provides oversight and direction to the CRO and service providers to accurately coordinate clinical study activities.
• Assists with Inspection Readiness activities which may require the development, modification and/or implementation of policies as needed to ensure high quality and integrity in all study activities.
• Coordinate clinical study timelines with Project management and escalate issues that may impact timelines/ deliverables.
• Leads and/or participates in the development and review of study documents including CRF design, project plans, Service Provider Oversight plans, TMF (Trial Master File) plan.
• Follows processes and procedures and recommend changes to SOP’s and policies to ensure comprehensive and compliant processes in the clinical operations organization.
• Identifies potential study issues/risks, escalates as needed and recommends/implements solutions.
• Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data review / clean up.
• Provide regular updates to Study lead and other stakeholders; Proactively identify, manage, or escalate issues appropriately.
• Coordinate with Study Lead and Finance to track vendor accruals and financial status against budget
• Prepares or reviews clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions.
• Monitors study progress for possible changes in study scope to ensure timely change order.
• May have some responsibility for the oversight and management of the study budget including site and service provider budgets.
• Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team.
• Ensures oversight of data and information in study specific systems eg. EDC, CTMS, eTMF is current and accurate.
• May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards.
• Other supportive duties as assigned to achieve operational objectives.

COMMUNICATION & INTERPERSONAL SKILLS

• Must have high quality written and oral communication skills, with the ability to convey overall objectives and maintain open lines of communication between the internal stakeholders and service providers.
• Must have negotiation and project management skills with the ability to coordinate across projects/program/timelines.
• Ability to integrate into and collaborate effectively with a remote cross-functional team environment (US, APAC, EU) with a positive attitude.
• Ability to prioritize and handle multiple activities daily yet flexible and responsive to frequently shifting priorities.
• Models our core values: Passion, Integrity, Innovation, and Patient Focus

CORE COMPETENCIES, KNOWLEDGE, AND SKILL REQUIREMENTS

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
• In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials.
• 3 days a week on-site in the South San Francisco office (flexible)

REQUIREMENTS

Education

• Bachelor’s degree or equivalent (scientific or healthcare discipline preferred)

Experience

• 7+ years of experience in a biotech or pharmaceutical company, leading cross-functional clinical activities with increasing responsibility and scope
• Minimum of 3+ years study management experience in clinical and drug development, including management of studies outsourced to CROs.
• Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs.
• Experience in supporting SOP development and implementation is desired.
• Experience working on global teams is desired, Asia-Pacific and EU highly preferred.

TRAVEL - Up to 30%