Sr CTM

Job Description

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

CORE COMPETENCIES, KNOWLEDGE, AND SKILL REQUIREMENTS

REQUIREMENTS

Education

Experience

TRAVEL - Up to 30%

Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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