Formation Biologics: Senior Regulatory Manager

Job Description

The Regulator Manager reports to the Director of Clinical Operations/QA who bears primary responsibility for managing Formation Biologics obligations as identified for clinical trial management and execution. This position requires project management responsibilities and includes the development of tools to assist in source documentation of clinical trial oversight and quality control.

Responsibilities

  • Adapt local Informed Consent Form (ICF) to local site requirements
  • Organize translations of the ICF with research sites as needed
  • Obtain essential regulatory documents for study start up at research sites
  • File and maintain a database to ensure regulatory document updates are obtained on time
  • Provides oversight of eTMF system
  • Authorize release of Investigation Drug Product to sites
  • Maintains a regulatory plan for studies
  • Ensure Standard Operating Procedures are established for all Formation Biologic regulatory delegated tasks
  • Print and ship study binders to approved sites, maintain a virtual site with documents
  • Facilitate site payments after monitoring visits and query resolutions
  • Maintain clinicaltrials.com website
  • Obtain and distribute study specific data (TBD) on a routine basis to identified Formation Biologics team
  • Participate in CRO activities as identified
  • Maintain a master file of monitoring visits and issues identified
  • Assist in the management of the day-to-day clinical operations, including management of vendors (e.g., CRO)
  • Coordinate and plan for the availability of clinical and non-clinical supplies necessary to meet study requirements
  • Support the Austin office in administrative tasks as requested (e.g., filing, data entry in logs, conference call invites, travel requests, etc.)
  • Other duties as assigned
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    Qualifications and Experience

  • Minimum of 3 year’s experience in Research, some in Oncology is preferred
  • Held responsible roles in the conduct and management of Phase I and II clinical trials
  • FDA Regulatory experience
  • Minimum Associate Degree in health sciences (preferred).
  • Proven ability to manage clinical trials
  • Is a self- starter and comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment
  • Willingness to offer full accessibility and thrive within a transparent work environment
  • Ability to maintain confidential information with a high regard for integrity
  • Excellent oral and written communication skills while continually demonstrating high levels of interpersonal versatility within diverse populations
  • Strong strategic, analytical and critical thinking skills
  • Ability to build relationships and establish credibility appropriately
  • Self-reliant and results oriented. Drive balanced with patience
  • Ability to prioritize and successfully execute multiple tasks simultaneously
  • Excellent project management skills
  • Proficiency with MS Office suite, Adobe, CTMS, etc.
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    How to Apply

    Please submit your CV and cover letter in PDF format to careers@formationbiologics.com. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.

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