Title: Senior CTM
Type: 12-month contract w/extension possibilities
Role & Key Responsibilities
- Serves as a member of one or more global crossfunctional Protocol Execution Team(s) (PETs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the clinical development plan: Participates in developing and finalizing crossfunctional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central / specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker / sample management plans, TMF, and CSRs.
- Liaises with cross-functional team members including the PET members to solicit input.
- Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial/medical monitoring, TMF. Ensures TMF creation and QC completion.
- Supports EDC and CTMS systems and data maintenance.
- Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions.
- Provides strategic operational input on protocol feasibility.
- Provides input to the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution to Protocol Execution Team Lead (PETL).
- Participates in selection of vendors (participates in the Request for Proposal (RFP) process), on a global scale, in collaboration with the PETL Utilizes outputs from operational analytical tools to enhance and improve study execution.
- Oversees delegated outsourced activities to ensure CRO and vendor delivery against contracted scope of work.
- Contributes to global study site selection & management: Conducts global protocol, country, and site feasibility assessments.
- Assists with all activities related to global site selection, contracting, set-up and maintenance.
- Ensures accuracy and timeliness of CTMS, timeline planning tools and other core systems. Ensures study adherence to ICH/GCP and SOP
- The capabilities required for this role are for a proven leader with the ability to manage delegated aspects of the study with minimal direction, is self-aware and takes initiative to fix and learn from mistakes, demonstrates good judgment in seeking guidance and exercises professionalism.
- Experienced in managing aspects of one or more early development phase (I and II), global, complex, clinical studies and generally experienced in clinical research/development.
- Highly effective verbal (including oral presentations) and written communication skills in English; effectively delivers key messages; aptitude to independently communicate with teams and stakeholders.
- Experience with effective vendor management.
- Aptitude to interpret outputs from analytical tools to enhance and improve study execution.
- Self-motivated, achievement-driven and exhibits ability to work with minimal guidance.
- 5+years of trial management experience in clinical and drug development.
- Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.
- Work on nights or weekends is not typically required, however, interaction on global clinical studies requires flexibility for occasional teleconferences / meetings outside of core working hours.