Join Our Crew

Responsibilities Include

• For assigned clinical studies, provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure. Manages all aspects proactively.
• Perform hands-on activities not outsourced to vendors, as needed.
• Author study documents and plans such as ICF and study specific plans.
• Provide input and review of site training materials
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate.
• Proactively identify risks and lead team members to mitigate risks in a timely fashion.
• Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators).
• Select and manage vendors.
• Perform and document study-level Sponsor Oversight of outsourced clinical activities.
• Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms.
• Initiate and manage study-level timelines and enrollment, including communication to internal and external team members on deliverables.
• Attend and present at study initiation visits (SIVs) and other site trainings/meetings.
• Serve as escalation point for site issues.
• Oversee monitoring activities, including report review.
• Support site supply management (e.g. lab kits, site tools, paper scales, thermometers, etc,)
• Perform periodic review of clinical data, quality metrics and study deviations.
• Review clinical monitoring reports to ensure timely completion and identification of issues.
• Manage laboratory samples to be sent to vendors in order to meet trial deliverables.
• Participate in testing of clinical trial systems/databases (i.e. UAT).
• Work with finance team to review and approve study and site budgets and budget templates.
• Provide critical thinking and escalation when issues arise during execution of clinical studies.
• Act as a liaison with other internal and external functional departments including quality assurance, data management, document management, regulatory, safety, translational research, clinical supply management, etc.
• Ensure high quality and compliance of work products to internal SOPs and external regulations to avoid unacceptable risk to the projects and functional area.
• Use project management analytical methods to assess progress and risks for assigned studies.
• Oversee, lead and train study-specific team members as needed.
• Provide mentoring to assigned contract and permanent Clinical Operations staff (e.g., CRAs and CTAs).
• Support Clinical Operations departmental projects including continual process improvement initiatives and SOP development.
• Perform other duties as needed.

Required Qualifications

• Bachelor’s Degree or advanced degree in life sciences or related field.
• Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience. Cell therapy experience preferred and/or focus complex therapies.
• Fluency in English; working proficiency in additional European languages a plus
• Experience with early phase, complex trials.
• Experience managing Contract Research Organizations and other external vendors (e.g., central laboratory vendor, etc.).
• Good understanding of European regulatory requirements (EMA, MHRA, etc). Working knowledge of GCP/ ICH regulatory guidelines
• Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management.
• CRA or CRA oversight experience in European sites preferred.
• Proven record of site and investigator/KOL interaction.
• General knowledge of other clinical trial functional areas and their respective deliverables including, regulatory affairs, data management, safety, medical monitoring, and medical writing.
• Strong attention to detail, good organizational and communication skills
• Ability to work independently and interact with senior management on a regular basis.
• Demonstrated leadership skills.
• Strong problem-solving skills with a solution-focused approach.
• Proficient with project management tools and analysis of metrics.
• Ability to travel to clinical sites as needed.
• Strong team orientation and passion for continuous self-development.

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