Senior Clinical Trial Manager

EyePoint Pharmaceuticals, Inc.-posted 2 months ago
$146,260 - $184,713/Yr
101-250 employees
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for preventing blindness through vision-saving medications, delivering best-in-class proprietary pharmaceutical technologies, and transforming ocular drug delivery. This position is reporting to the Associate Director, Clinical Operations and is remote. EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

  • Ensures that delegated components of clinical trials are executed to expected and specified quality standards.
  • Expands basic knowledge of clinical trials operations and scientific principles and objectives of EyePoint’s clinical trials under some direction and guidance of senior staff but largely self-directed.
  • Builds best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectations.
  • Manages study processes or efforts under the supervision of the Associate Director of Clinical Operations.
  • Authors/reviews/contributes to clinical study documents.
  • Reviews and approves study related plans generated by Clinical CROs and vendors.
  • Provides input as the subject matter expert for the study during regulatory inspections.
  • Executes the clinical study in accordance with the project clinical development strategy and timelines.
  • Contributes to the review of international study documents and responsible for their local adaptation when necessary.
  • Accountable for the timely clinical review and/or approval of Case Report Forms, User Acceptance Testing (UAT), and provides clinical input into corresponding completion guidelines.
  • Responsible for oversight of identification and selection of investigator sites.
  • Responsible for planning and conducting investigator’s meetings in cooperation with the respective departments.
  • Ensure the delivery of clinical trial supplies in collaboration with the clinical supply team.
  • Collaborates with the cross functional team on selection and management of clinical vendors.
  • Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
  • Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
  • Trains and manages CRO and other clinical vendor activities to ensure the quality meets EyePoint and regulatory requirements.
  • Monitors the status of clinical data collection of assigned clinical studies.
  • Ensures preparation for regulatory agency inspections by developing and executing readiness plans, managing documentation, and facilitating cross-functional collaboration to maintain compliance with GMPGDP standards.
  • May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
  • Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.
  • Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines.
  • Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site/CRO/clinical vendor contact.
  • Responsible for the availability and tracking all relevant study information/study metrics.
  • Oversees the resolution of data quality issues.
  • Reviews correspondence and monitoring reports relating to the study.
  • Evaluates CRO and vendor performance for future work.
  • Provides periodic status reports regarding study timelines, accruals, etc. to EyePoint Management as requested.
  • Reviews budgets and contracts with CROs, vendors, and investigative sites, as applicable.
  • Requests and critically evaluates proposals and change orders from CROs and vendors.
  • Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
  • Understanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance preferred.
  • Knowledgeable of current FDA and local IRBs regulatory requirements and guidelines governing clinical research.
  • Ophthalmology experience strongly preferred.
  • Bachelor’s degree or nursing degree is required. Scientific/health care field preferred, but not required.
  • 5+ years’ experience working in clinical operations within a pharmaceutical company or CRO or similar organization.
  • Experience of at least 3 years as a Clinical Trial Manager/Project Manager or similar position within a pharmaceutical company or CRO.
  • Strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
  • Ability to work independently and take initiative.
  • Ability to work/communicate successfully within a cross-functional team.
  • Strong knowledge of applicable computer and project management software packages.
  • Familiarity with financial budgeting and forecasting or reporting.
  • Excellent written and oral communication skills.
  • Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization.
  • Previous experience directing inspection readiness strongly preferred.
  • Global clinical trial experience and the ability to lead/manage more than one clinical trial.
  • Competitive salary range of USD $146,260.00 to $184,713.00 per year.
  • Robust total rewards package.
Track Jobs with Teal

Job Search Resources

•
Resume Builder
•
Senior Case Manager Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service