Director, Clinical Systems & TMF Operations

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:

This individual will provide tactical support and strategic guidance on TMF processes, filing conventions, index creation, maintenance, and other TMF related matters. A successful candidate will serve as a key leader and partner with internal cross-functional stakeholders and external suppliers to establish and uphold company standards and processes, achieve efficient set-up and implementation, and ensure oversight of systems and documentation across Rocket programs/trials, in compliance with Rocket SOPs, applicable global regulations and guidelines (e.g., ICH/GCP, FDA, EMA), and industry best practices.

As a key change agent within the organization, this role will drive change management and promote the adoption of enhanced processes, standards, and innovations.

Responsibilities:

TMF Operations:

• Responsible for overall strategy and management of TMF Operations within the Global Clinical Development organization.
• Develops and implements innovative strategies to enhance TMF, records management, and other clinical trial documentation systems and processes, leverage technology, and ensure seamless operations.
• Provide a robust framework to evaluate the overall health of the TMF, ensuring quality, completeness, accuracy and timeliness of the TMF for Rocket clinical trials and ensuring inspection readiness.
• Lead the development & ongoing maintenance of global standards, standard operating procedures (SOPs) and corresponding controlled documents (e.g., user guides, checklists, QC materials, etc.) that are in line with relevant regulatory regulations (e.g., ICH-GCP, and regulatory requirements such as EMA and MHRA) and industry best practices (e.g., TMF Reference Model).
• Lead the development and implementation of standardized TMF training processes and provide guidance to the cross-functional stakeholders on the Study Execution Teams on TMF expectations, tools, procedures and compliance requirements.
• Oversee internal (TMF Project Leads & Document Specialists) and/or vendor staff on day-to-day eTMF start-up, maintenance, filing and close-out activities, ensuring that assigned TMF personnel for each program perform the following responsibilities

o Set-up of Veeva eTMF instances for all new clinical studies during the study-start-up period

o Collaborate with and support the Functional representatives on the Study Execution Teams in defining and maintaining expected study documents throughout the study cycle, including ensuring appropriate maintenance of expected documents in the TMF.

o Collaborate with Quality Assurance to conduct inspection readiness checks/quality reviews of TMF documents and across sections of the TMF (e.g., trial, country, site) and work with internal and external team members to ensure that any findings are resolved satisfactorily and within a timely manner.

• Oversee quality control activities across the Rocket portfolio to ensure all study-specific TMFs are inspection ready.
• Develop, implement, and provide standard TMF metrics/KPIs to share with Clinical Quality Assurance, Study Execution Teams, and Rocket Leadership to demonstrate document quality, TMF completeness, and process compliance. Identifies trends and areas for improvement and implements support measures. Lead efforts with all internal & external Study Execution Team stakeholders to address gaps, issues and mitigate risks.
• Serve as the SME for TMF during internal and external inspections and audits; collaborate with Study Execution Teams and regulatory authorities on TMF-related inquiries and inspections.

Clinical Systems & Technology:

• Act as primary point of contact for the company’s evaluation, configuration, implementation, and management of existing & future clinical systems e.g., CTMS, clinical biospecimen lifecycle management system, etc.).
• Provides leadership and expertise to build and deliver CS+T strategy and initiatives, in conjunction with IT department, to support Clinical Development organizational business objectives.
• In Collaboration with IT, evaluates industry changes and trends and proactively identifies and offers recommendations for organizational preparation/adoption of future capabilities related to trial technology and systems.
• Develops business cases around clinical systems & technology, implements solutions, and measures effectiveness.
• Partners with cross-functional team members (e.g., Clinical Operations, Data Management, Clinical Supply, Biospecimen Operations Management, QA, IT, Procurement) to identify and select CS+T supplier(s), and ensure effective onboarding and implementation.
• Collaborate with IT and Business Operations teams in oversight of the CS+T vendors and ensure both the quality and timeliness of their work.
• Identifies areas of opportunity, mitigates risks, and provides solutions to identified problems.
• Oversee contracting and budget management activities including establishing an initial Scope of Work (SOW) and Change Orders, as applicable.
• As Business Owner, ensures processes, tools, documents, and training materials related to clinical systems and technology are developed and implemented, as appropriate.
• Acts as primary business change agent within Clinical Operations to ensure adoption of new capabilities and business processes related to clinical systems and technology.

• Provides functional leadership and strategic direction to the TMF Operations team, ensuring ongoing operational excellence.
• Responsible for the management and leadership of direct reports (e.g., TMF Project Leads and Document Specialists) including recruitment, training, mentoring, career development, work assignments, performance evaluations, and ongoing feedback.
• Partners with Head of Clinical Operations to forecast resource demand and perform capabilities assessments for CS&T and TMF Ops teams.
• Stays abreast of industry regulations and guidance updates/changes and provides relevant and timely training for the department.
• Builds and maintains collaborative business relationships with cross-functional partners as well as external vendors, ensuring expectations are clear, and deliverables met.
• Participates in CRO/Vendor Governance committees, as appropriate.

Qualifications:

• Bachelor's degree in a clinical, scientific, or related discipline.
• 10+ years demonstrated industry experience, with 8+ years of progressive experience in a TMF and/or Systems Management role with a Sponsor/CRO.
• Prior experience with Veeva Vault eTMF is required.
• Prior experience with Veeva Vault CTMS and other Clinical systems highly desired.
• Extensive knowledge and experience in clinical trial documentation and TMF Reference Model filing structure
• Proven track record driving effective TMF-related initiatives.
• Experience with collaborating with clinical vendors/CROs.
• Experience authoring/reviewing procedures (SOPs, WIs) in a GCP environment is required.
• Experience in clinical trial conduct in a global environment is a plus.
• Previous gene therapy, rare disease or oncology experience highly desired.

• Strong knowledge and understanding of applicable regulations, guidelines (e.g., ICH/GCP, FDA, EMA), and industry best practices pertaining to the Trial Master File management.
• Ability to develop, execute, and evaluate strategies to improve process and set direction in the TMF space.
• Advanced Project Management skills, particularly regarding management of timelines, budget, communication, resources, and quality
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• Excellent communication (written & verbal), presentation, and negotiating skills.
• Excellent interpersonal skills and able to work in a matrix environment both internally and externally; can foster relationships & always maintain professionalism.
• Demonstrated strengths in conflict management & timely issue escalation.
• Strong leadership skills, including the ability to analyze, evaluate and prioritize key issues and problems, and subsequently seek-out and recommend possible solutions and mitigation strategies before escalation.
• Proven flexibility and ability to lead and drive collaboration in a fast-paced, dynamic cross-functional team environment and manage competing priorities.
• Demonstrated ability to work independently as well as in a team environment.
• Experience in managing staff is required.
• Ensure an enthusiastic and open attitude towards continuous professional development.
• Advanced computer skills (Word, Excel, Outlook, PowerPoint) or equivalent required.

Office Environment. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role.

Travel Requirements: Less than 5% travel, as needed

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.