Senior Clinical Project Manager
Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The Opportunity
As the Senior Clinical Project Manager (Sr. CPM), you will be the primary operational contact for the study, the lead for the cross-functional team in the execution of the study. This individual is responsible for the planning and implementation of one or more clinical trials within a therapeutic area. The Sr. CPM provides operational leadership to the clinical operations team to ensure project milestones delivery on time, within the budget, high quality and in compliance with the ICH-GCP, Regulatory guidelines and all applicable SOPs/Work Instructions. The Sr. CPM should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) utilizing effective communication across organization. This position may include line management responsibilities. The incumbent will also be able and willing to mentor junior staff and perform additional duties or functions as required.
What You'll Be Doing
- Responsible for all operational aspects and progress of clinical trial from a study planning activity to study execution including ongoing tracking of all applicable performance metrics and quality indicators.
- Develops and maintains the clinical trial deliverables including timelines and budget
- Serves as an escalation point and resource for internal/external teams and investigational sites; partners with cross functional teams to achieve deliverables.
- Oversees/facilitate with Clinical Development a country and site feasibility/selection process, subject recruitment and retention strategy and related activities
- Provides operations and strategic input and/or approves study documents such as synopsis, protocol, ICF, eCRFs, eCRF Completion Guidelines, Study Plans and Manuals, and Clinical Study Report development, etc.
- Responsible for management of CTT team meetings and other internal meetings as required
- Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues and queries as needed and implements risk management concept as appropriate
- Responsible for and participates in clinical service provide (vendor) selection and development of scope of work, budget, and establishing the project timelines as a part of outsourcing activities.
- Provides oversight for all vendor operations activities (e.g., study management, monitoring, specifications development, UATs, issues escalations)
- Responsible for the selection and oversight a study specific and GCP training of CRO study staff, clinical monitors, investigational sites and vendors
- Manages CRO/vendor agreements, ensuring that change orders and budgets meet clinical operations specifications including review and approval of study invoices and ensuring their accuracy according to the contract and work performed by the CRO/vendor
- Oversee/responsible for the eTMF set-up ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages.
- Ensure that all aspects of GCP compliance and audit readiness are maintained thought out trial conduct
- Conducts Sponsor quality monitoring/oversight visits to sites and /or CRA performance assessment in adherence to GCP, corporate SOPs and protocol as needed
- Creates, manages, measures, and reports timelines for milestone deliverable
- Proactively manages/identifies potential study issues/risks and recommends/ implements solutions with key internal/external stakeholders
- Prepares metrics and updates for management
- Oversees internal team meetings, investigator meetings, and other trail specific meetings
- Participates in the development, review, and implementation of departmental SOPs, WIs, initiates and processes improvement
- Strong understanding of the cost drivers and are accountable for the development, management, reconciliation of overall study budget
- Collaborates in the development/management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines
- Review and approves vendor invoices and managers accrual and payment process for all clinical trial vendor including investigative sites
- Participates in the development of creative solutions in management of clinical trial, updates and/or development of working instructions and SOPs, document management, clinical operations personnel training, and review/updates as needed in quality control processes
- Contributes to wider organizational goals and/or activities as assigned
- Maintains completion of required corporate training on standards, policies, work instructions by due date
- Mentors clinical operations personnel in clinical trial execution
- Supports the Clinical Operations Lead and clinical trial team by performing other tasks as needed
- Must be able to travel up to 25% of the time
- It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
- Bachelor’s degree in scientific discipline. Advanced degree (MA/MS, Pharm D; Ph D) preferred
- Minimum of 7-8 years progressive experience in clinical research management experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting with 1+ year of supervisory experience (Sponsor company is preferred)
- Experience in management of external vendors, e.g CROs
- Familiar with advanced concepts of clinical research and ability to work effectively in a team/matrix environment
- Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results
- Demonstrates strong understanding of medical terminology and clinical trial design concepts and activities in relation to execution of the Clinical Development Plan
- Experience working with biologics preferred
- Knowledgeable in clinical research practices, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required
- Global study execution and experience with various health and ethics agencies.
- Experience in managing cross functional team members during trial execution.
- Ability to function in a fast pace, dynamic environment and dealing with ambiguity.
- Proven complex problem solving and decision-making skills
- Must be a demonstrated self-starter and team player with strong interpersonal skills
- Strong interpersonal and negotiation skills
- Excellent written and verbal skills
- Must display strong analytical and problem-solving skills
Why Should You Apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.
We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!
In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.
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