Senior Clinical Research Associate

Overview:

Work at ROCKET PHARMA and help cure rare diseases!

In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Position Summary:

The Sr. CTM will serve as an Subject Matter Expert in an operational area outside of their assigned studies (Veeva, Ex-US regulations, etc.).

Responsibilities:

1. 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.

1. 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 for escalation of clinical site-related issues; work with CRAs 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.

1. 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.

1. 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.
• Overall responsibility for study milestone, maintenance, study logs and deliverables in Veeva CTMS
• Oversee eTMF set-up, maintenance, and close-out activities in conjunction with Rocket CRAs and CRO personnel and overall responsible for completeness
• 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

1. 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.

1. Non-Study Activities

• Leader in Clinical Operations funding to contribute expertise to departmental and cross-functional process improvement activities.
• Subject Matter Expert (SME) in operational aspect to serve as point of contact and mentorship for questions and escalations.
• Participate in creation and/or revisions of department SOPs and work instructions.
• Mentorship of junior Clinical Operations staff.

Qualifications:

Education/Experience and Skills Requirements:

• Bachelor’s degree required, preferably in health care or life sciences or other related field of study.
• 10+ years of relevant clinical trial experience in the pharmaceutical or biotech industry.
• Minimum of 5 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.

Required Skills:

• 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 (Rave), CTMS and eTMF (Veeva) platforms.
• Experience in developing training and/or informational material and presenting to both internal and external stakeholders.
• Experience in regulatory filings (e.g., NDA, BLA, MAA) highly desired.

Desired Competencies:

• 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%

Compensation:

Salary range - $124,000.00 - $142,000.00

At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee’s experience, location of the position and availability of similar talent in a competitive market.

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.