Rocket Pharmaceuticals

Clinical Trial Manager

Location US-NJ-Cranbury
ID 2024-1990
Category
Clinical Operations
Position Type
Regular Full-Time

Overview

Work at ROCKET PHARMA and help cure rare diseases!

 

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Position Summary

This position reports through the Associate Director, Clinical Operations which is accountable for overall clinical execution and provides operational input during protocol development, oversight of study conduct, and interpretation of study results. The Clinical Trial Manager (CTM) will be responsible for the operational aspects of planning, implementation, and execution of clinical studies.  The CTM will drive collaboration with the internal and external Study Team for operational deliverables to ensure expected timelines, quality standards,  Good Clinical Practices and applicable regulations are being met throughout study development, maintenance, and close out. The CTM is responsible for Study Planning and Conduct providing strategic input into study tools (study specific documents, regulatory preparation for local HA/IRB submissions). The CTM will oversee internally and outsourced study models. The CTM may have the opportunity to work on highly complex global multi-country studies in a cross-functional team, matrix environment The CTM should be able to prioritize tasks to timely obtain results with an emphasis on high quality outcomes, utilizing available performance and quality metrics and study timelines. The CTM should utilize strategic and critical thinking skills to ensure study success and set and manage expectations on deliverables. The CTM will also act as a mentor to the operations team members to utilize expertise and promote collaboration cross functionally to ensure successful outcomes.

Responsibilities

  • Study Planning & Start-up:    
    • Lead study feasibility assessment activities
    • Lead enrollment strategy and plan for the study
    • Contribute to the development and review of critical study documents, such as study protocol, eCRF, ICF, etc.
    • Work with key stakeholders to oversee the timely development and finalization of key study plans and manuals (Pharmacy Manual, Laboratory Manual, eTMF Plan, Monitoring Plan, etc.)
    • Provide input and guidance on operational considerations to protocol development.
    • Lead clinical site identification, qualification, selection, and activation activities for the study, including activities such as site and staff training, site ICF and coordination of site investigator contracts and budgets with Procurement & Legal groups.
    • Lead the planning and conduct of all Investigator Meetings (IM) in collaboration with other key Rocket stakeholders on the Study Operations Team and CRO/vendor personnel.
    • Provide input on study activity timelines and study budget inputs.
  • Study Enrollment and Maintenance:
    • Continuously reviews study progress, providing updates to the broader team and ensuring concerns are appropriately communicated to relevant stakeholders in a timely manner, manage risks, and develops and follows through on mitigation plans.
    • Manage input to, and implementation of, patient recruitment and retention strategy plan in conjunction with Clinical Medical Leads.
    • Oversee and direct study team members on clinical monitoring and site activities to ensure the integrity, accuracy, and accountability of clinical data, as well as compliance with GCP, applicable regulations and the study-specific Clinical Monitoring Plan
    • Oversees the monitoring trip report process, including review and approval of individual trip reports and ensuring resolution of all action items related to Rocket and/or CRO responsibilities.  
    • Act as primary Point of Contact for CRAs and CTAs for escalation of clinical site-related issues; work with CRAs/CTAs to develop mitigation strategies and action plans to ensure successful resolution of all site-related issues.
    • May participate in on-site monitoring visits as needed or accompany junior team members or CRO monitors for training purposes; will conduct Quality Assurance visits to assess site and CRA capabilities and compliance.
    • Review clinical site invoices for completeness and accuracy, in alignment with the site’s Clinical Trial Agreement and site budget.
    • Organize and lead regular teleconferences with Principal Investigators, clinical site staff, and key Rocket stakeholders throughout the study life cycle to discuss site-level enrollment, operational and strategic issues.
    • Work closely with Rocket Biospecimens team and specialty vendors to ensure samples are being received and analyzed according to study team/protocol expectations.
    • Collaborates with eTMF Managers to ensure complete and accurate study filing and maintenance.
    • Reviews study documents (Protocol Deviation logs, patient trackers, monitoring reports, etc.) for timely and compliant completion.
  • Study Closure:
    • Oversee all study closure activities (sites, reconciliation activities, filing & archiving, and e/TMF related activities)
    • Participate in cross-functional data listing reviews.
    • Ensure timely delivery of clinical documents for the CSR and appendices.
  • Study Team Management & Leadership:
    • Ensure timely and quality execution of study according to the protocol, study execution plan, and GCP guidelines (including Rocket SOPs, ICH and FDA and other Health Authorities (HAs))
    • Partner with Clinical Medical Leads in managing Study Operations Teams for assigned studies, holding cross-functional representatives accountable for achieving assigned deliverables within timelines, budget and in accordance with Rocket’s quality standards.
    • Act as main Point of Contact for all Clinical Operations study activities and represent Clinical Operations on the Study Operations Team and to associated sub-teams.
    • Acts as a mentor for the Clinical Operations study team members providing appropriate guidance and training.
    • Provide regular study quality and progress updates to Study Operations Team, and other key stakeholders.
    • Prepare and communicate study dashboards of standard metrics (KPIs, SQMs) to routinely monitor team activities and ensure compliance to timelines, quality, and budget.
    • Identify Clinical Operations risks and mitigations and align with cross-functional Study Operations Team on overall Risk Mitigation Plan
    • Identify, resolve or, if necessary, escalate Clinical Operations issues that have a significant impact to overall study timelines, other functions, budget or quality to Clinical Medical Leader and Associate Director of Clinical Operations
    • Manage protocol deviation reviews in collaboration with key Rocket and CRO stakeholders.
    • Lead the impact analysis and implementation of protocol amendment changes for cross-functional teams and contributing vendors. 
    • Collaborate with Clinical Supply Manager and Biospecimen Operations Manager to provide forecasts for all necessary clinical supplies, including Investigational Product, laboratory supplies and ancillary supplies.
    • Oversee eTMF set-up, maintenance, and close-out activities in conjunction with Rocket CTAs and CRO personnel.
    • Coordinate with Clinical Quality Assurance and Regulatory for planning for Quality Assurance audits (e.g., internal, clinical sites & vendors) and/or HA inspections.  Participates in audits and regulatory inspections, as applicable.
    • Keep Study Operations Team driving to be in a state of constant Inspection Readiness
  • Vendor Management:         
    • Lead cross-functional vendor evaluation and selection activities for key study vendors.
    • Collaborate with Procurement group on the evaluation and selection of CRO and key study vendors, including negotiations on CRO/vendor contracts and budgets, organizing, and conducting bid defense meetings, and analyzing detailed financial drivers.
    • Oversee the planning and conduct of all CRO and vendor Kick-Off Meetings
    • Oversee day-to-day management of CRO and vendors’ contracted activities as per vendor oversight and governance plans.
    • Work with Procurement & Finance to ensure final payments to vendors at study closure.
  • Non-Study Activities
    • Contribute expertise to departmental and cross-functional process improvement activities.
    • Participate in creation and/or revisions of department SOPs and work instructions.

Qualifications

  • Bachelor’s degree required, preferably in health care or life sciences or other related field of study.
  • 8 years of relevant clinical trial experience in the pharmaceutical or biotech industry.
  • Minimum of 4 years managing all aspects of clinical trial activities (start-up through close-out) including vendor management, preferably in a global environment
  • Direct clinical monitoring and site management experience is required.
  • Experience in gene therapy, rare/orphan disease highly desirable.
  • Experience in regulatory filings (e.g., NDA, BLA, MAA) highly desired.
  • Thorough, integrated knowledge of all Clinical Operations and site management/site monitoring activities using ICH/GCP
  • Understanding of the overall drug development process.
  • Ability to troubleshoot site-related issues and provide solutions and mitigation strategies.
  • Prior experience working on cross-functional teams in a lead capacity.
  • History of successfully developing effective relationships with outside vendors, CROs, and central/specialty labs
  • Demonstrated experience with EDC and eTMF platforms.
  • Experience in developing training and/or informational material and presenting to both internal and external stakeholders.
  • Ability to adapt and prioritize competing demands within a dynamic environment.
  • Outstanding organizational, time management, planning and record keeping skills.
  • Advanced skills in Project Management, particularly regarding management of schedule, budget, communication, resources, and quality
  • Advanced communication (oral & written), interpersonal and negotiating skills.
  • Ability to analyze, evaluate and prioritize key issues and problems, and subsequently seek-out and recommend possible solutions and mitigation strategies before escalation.
  • Ability to effectively lead cross-functional meetings.
  • Proficient in MS Office tools (Excel, Word, PowerPoint, Outlook & Teams), SharePoint.
  • Work well within a team setting, proactively expanding one’s network and work relationships outside the department.

 Travel Requirements:  Ability to travel approximately 20%

EEO Statement

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

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