Senior Clinical Trial Manager

Recruiter
Regeneron
Location
Tarrytown
Salary
Competitive
Posted
Jul 17, 2017
Closes
Jul 19, 2017
Industry
Computer
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
The Sr. Manager, Clinical Trial Management is responsible for leading or participating in one or more cross functional study teams (and/or sub-teams) to deliver clinical research studies on time, within budget and with good quality in compliance with Regulatory Authorities regulations/guidelines and Regeneron SOPs/WPDs. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with therapeutic area medical director(s) and assigned therapeutic area project manager.

Responsibilities:
Study Team Leadership
  • May lead cross-functional study team (s) and/or sub-team(s)
  • Builds, manages, and maintains budgets, contracts and timelines for a given clinical trial
  • Prepares content for training materials and coordinates training on study procedures
  • In collaboration with medical director for study, creates study plans and study specific working practices
  • Establishes study team contacts, roles, responsibilities, and objectives
  • Develops, manages, and maintains relationships with external partners
  • Develops study execution plans and risk management plans
  • Facilitates effective communication between study sites and study team members to ensure ongoing successful execution
  • Provides ongoing mentoring and guidance to CRAs/CTAs
  • Establishes and executes risk management plans when required
Study Planning
  • Serves as project manager for the functional area in managing protocol execution.
  • Oversees study planning and timelines to ensure alignment with overall clinical development plan
  • Works with management to determine resourcing needs
  • With input from therapeutic area medical directors, leads the development of study documents including protocols, informed consent forms, and study manuals
  • Develops study budgets
  • Responsible for meeting timelines of investigational product manufacturing, labeling, release and management
  • Oversees setup and management of CTMS and the TMF
Selection and Evaluation of Investigative Sites
  • Participates in country selection
  • Reviews feasibility data
  • Identifies prospective investigative sites and participates in final investigative site selection
  • Liaises with vendors to ensure quality site selection
  • Oversees negotiation of financial terms of individual site budgets
  • Manages/oversees site payments
  • Monitors GCP/ICH site level compliance
Identification and Selection of Vendors
  • Participates in preparation of RFP, assumptions and SOW
  • Recommends vendors
  • Contributes and reviews specs for affiliated vendors (IVRS, Labs)
Vendor Management
  • Oversees all aspects of vendor management (performance, quality, timelines, deliverables, costs)
  • Provides input, reviews, and approves vendor study specifications
  • Ensures appropriate escalation of issues as they arise
  • Reviews and approves/scrutinizes specified costs on vendor invoices against contract
  • Participates in design and approval of various project and communication plans
  • Prepares detailed study timeline
Preparation of Study Documentation
  • Reviews essential regulatory documents
  • Establishes and oversees risk management plan
  • Prepares, reviews and approves Monitoring Plan
  • Assures adherence to Monitoring Plan
  • Reviews eCRF specs (EDC) and reviews CRF completion guidelines
  • Designs, reviews and approves study tools (for investigative site use)
  • Facilitates development, reviews, and approves Data Management documents (CRO and in-house studies)
Input Clinical Database, Safety and CSR Reports
  • In collaboration with Data Management, develops procedures and tools for data collection
  • Oversees collection of data to ensure compliance with protocol and clinical research project objectives, FDA/ICH/GCP regulations and guidelines
  • Reviews edits specifications (paper and EDC)
  • Executes EDC/IVRS User Acceptance Testing (UAT) scripts
  • Facilitates development and review of Clinical Data Review Plan
  • Reviews Summary Reports
  • Facilitates data review meetings
  • Participates in SAE reconciliation
  • Reviews and compiles CSR and appendices
Initiation and Site Start Up
  • Prepares and reviews material for investigator meeting and CRA Training
  • Conducts CRA training
  • Plans/organizes/leads Investigator meeting
  • Provides oversight of country regulatory approvals (e.g. CTA, MoH)
  • Oversees country/site IRB/EC approval
  • Reviews regulatory package (essential documents - blank forms and templates for 1572s, financial disclosure, etc.),
  • Obtains appropriate country/site insurance
  • Authorizes investigational product shipment to investigational sites, including (in association with Regulatory Affairs) the initial shipment
  • Reviews and approves informed consent forms (e.g. site or country specific ICFs)
Enrollment of Subjects
  • Ensures enrollment is tracked and recorded appropriately
  • Compiles and reports enrollment status to senior management
  • Updates recruitment strategy
  • Addresses enrollment and retention issues
Maintenance of Sites, Subjects and Data
  • Provides oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced),
  • Reviews and approves monitoring trip reports
  • Reviews study data as defined by Study Team
  • Schedules and conducts CRA meetings /teleconferences
  • Follows up on outstanding eCRFs and data queries
  • Performs co-monitoring visits to ensure data integrity
  • Oversees resolution of study conduct issues
  • Addresses site issues found during audits
  • Compiles materials and data to support Data Safety Monitoring Board
  • Ensures ongoing reconciliation of TMF
Study Close Out
  • Manages/oversees study close out activities
  • Reconciles payments to investigative sites and vendors
  • Reconciles study budget
  • Completes all archiving
  • Reconciles TMF
Requirements:
Bachelors degree and 8-10 years relevant industry experience
  • Experience developing trial plans and extensive clinical research knowledge and a cross-functional understanding of clinical trial methodology.
  • Working knowledge of the clinical drug development process
  • Understands current and future business trends and information
  • Effective problem solving skills
  • Written, verbal communication and presentation skills in small and large group settings
  • Knowledge of ICH/GCP and regulatory guidelines/directives
  • Disease/therapeutic area knowledge
  • Leadership skills/negotiation skills, Mentoring/coaching, Ability to effectively multi-task and prioritize
  • Financial budgeting and forecasting skills
  • Project management/organizational skills. Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel
  • Study Tools including electronic system skills CTMS / EDC
  • Interpersonal skills
  • Cross functional and cross-cultural awareness
  • Ability to work in a matrix environment
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regenerons unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.