Senior Clinical Trial Manager

4 weeks ago

Chicago, United States Vanqua Bio Full time

Clinical Trial Manager / Senior Clinical Trial Manager


About the Company

Vanqua Bio is a biotechnology company located in Chicago, IL focused on developing novel therapies for Parkinson’s disease and related neurological disorders. Leveraging a state-of-the-art technology platform and biology insights from the founding team, the company is focused on delivering compelling therapeutics to patients. We offer an excellent compensation package including competitive base salary, company ownership and comprehensive benefits. Vanqua Bio also offers the opportunity to be part of a passionate and driven biotech team in downtown Chicago, IL.


About the Position:

We are seeking a highly motivated Clinical Trial Manager / Sr Clinical Trial Manager (CTM/Sr CTM) to lead the study team, vendors, clinical monitors, and clinical sites through the life cycle of a clinical trial. This individual will implement US and global Clinical Operations strategy for Vanqua Bio’s clinical trials in support of the company’s key strategic goals. As an early hire, they will be influential in contributing to the clinical trial design and execution and to Vanqua Bio’s culture. Experience in either rare or neurodegenerative diseases is a plus. Beyond the requirements listed below, the ideal candidate will possess an entrepreneurial attitude key to succeeding in a dynamic early-stage biotech.



Responsibilities:

  • Independently/proactively manage all aspects of one or more clinical studies within a program, including the study team and all external vendors.
  • Accountable for clinical trial timelines and providing status updates to stakeholders.
  • Develop and ensure execution of activities outlined in various study plans (e.g., sponsor oversight, monitoring, deviation, training, and study communication plans).
  • Liaise with clinical site staff and investigators as appropriate to ensure optimal sponsor-site relationships.
  • Lead and support Study Execution Team meetings.
  • Proactively escalate potential issues/risks and recommend/implement solutions.
  • Contribute to the selection of all CROs/vendors and serve as their point of contact, providing ongoing management to ensure execution of deliverables within the approved budget, study timeline, and study protocol.
  • Manage study contracting, budget, forecasting, accruals, and payment process for all clinical trial vendors including investigational sites.
  • Demonstrated ability to mitigate and escalate changes in scope appropriately.
  • Draft and coordinate review of relevant documents including study protocols, informed consents, monitoring plans, investigator brochures, and clinical study reports.
  • Ensure correct case report form (CRF) content is collected, prepare/implement CRF completion guidelines, and coordinate delivery of data listings and study reports.
  • Be accountable for clinical trial enrollment (e.g., develop recruitment strategies) and risk mitigations.
  • Support creation of standardized clinical trial tools, processes, and SOPs.



Education, Skills and Experience:

  • BS/BA required.
  • 3+ years of Clinical Operations experience in pharmaceuticals is required.
  • Rare/neurodegenerative disease experience a plus.
  • Ability to travel as required for the program.
  • Proven track record as a clinical trial manager, responsible for leading the internal study team, CROs, consultants, and vendors.
  • Clinical Operations experience across all phases of development from Phase 1-3 with emphasis on early phase development.
  • Demonstrated knowledge of FDA, ICH, and GCP guidelines.
  • Strong analytical and problem-solving skills at a project level.
  • Excellent oral and written communication skills.
  • Ability to deal with time demands, incomplete information, or unexpected events.
  • Outstanding organizational skills and ability to prioritize that enables multitasking and working within aggressive timelines.
  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
  • Strong team player with the ability to build relationships across and outside the organization.


Ideal candidate will be local with ability to come into the Chicago office on a regular basis. Remote candidates may be considered with the expectation that they travel 10% (anticipate at least one full workweek per month in the Chicago office).


Job title and level will be commensurate with candidates’ education and experience.


Vanqua is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.


If interested in this position, please send cover letter and resume via LinkedIn to pinellin@vanquabio.com. For security, resumes will not be accepted directly through email.


We are not accepting recruiter or recruiting firm assistance for this opening. Please do not send resumes to Vanqua employees or to the company location. Vanqua is not responsible for any fees related to unsolicited resumes.

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