Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

The Senior Document Specialist, eTMF will act as a primary TMF document processor for Rocket’s Electronic Trial Master File (eTMF). Successful candidates will be familiar with GCP, FDA regulations, and relevant Standard Operating Procedures for clinical research. The Senior Document Specialist should be familiar with TMF procedures and become familiar with company product development procedures. This position reports through the Clinical Operations function which is accountable for overall execution and conduct of company-sponsored clinical studies.

Primary Responsibilities:

• • As the primary point of accountability for the company’s Trial Master File processes and systems:
  • Assist in study start-up of the TMF
  • Assist in TMF Set up
  • Participate in document collection.
  • Contribute to drafting of TMF related work instructions.
  • Assist TMF access management.
  • Assist in TMF document filing
  • Verify metadata in TMF
  • Assist and facilitate development of study specific index
  • Assist entry of expected artifacts into TMF
  • Assist in training Rocket staff and TMF contributing vendors
  • Contribute to TMF plan development
  • Assist artifact contributors in filing documents within 30 calendar days
  • Conduct non-content check work flow in TMF
  • Assist in facilitating rocket study team in periodic quality check
  • Assist in conducting completeness check of study specific index
  • Assist in conducting logic check and completeness check of artifacts
  • Assist in reconciliation of required study specific artifacts in the Investigator site file and TMF
  • Ensure completeness, quality, and accuracy of Trial Master Files for clinical trials and ensure inspection readiness
  • Additional responsibilities as assigned by Clinical Operations Management, including but not limited to:
  • Travel to sites and assist in collection of TMF documents
  • Assist in reconciling of Investigator Site File
  • Collaborate with Clinical Trial Associates, Clinical Research Associates, Clinical Trial Managers, and Clinical Operation Directors assigned to specific clinical studies
  • Assist Clinical Operations staff in the collection and review of site regulatory package documentation
  • Participate in internal & external team meetings, in a positive, professional manner
  • Work closely with multiple functional teams, including Regulatory, Medical, Safety, Data Management, Legal, Finance and CMC.

Requirements:

• • Bachelor’s degree in life or health sciences or relevant industry experience in lieu of education will be considered
  • 5 years of experience with eTMF / clinical study file documentation processing
  • previous gene therapy, rare disease or oncology experience is a plus.
  • Prior experience with Veeva Vault eTMF
  • Prior experience with CTMS and other Clinical systems highly desired
  • Knowledge and understanding of ICH/GCP, Good Documentation Practices, and regulatory requirements as they apply to the Trial Master File.
  • Understanding of the impact of the TMF on Trial Management.
  • Detail-oriented with a high level of organizational skills
  • Excellent written and verbal communication skills
  • Excellent interpersonal skills; always maintains professionalism; ability to resolve conflict.
  • Ability to adapt within a dynamic environment
  • Ability to work as part of a cross-functional team and manage competing priorities.
  • Knowledge of computer skills (MS Teams, SharePoint, OneNote, Word, Excel, Outlook, PowerPoint) or equivalent required.

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.

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