Tvardi Therapeutics, Inc.
  • Sugar Land, TX, USA
  • Full Time

Clinical Project Manager

About Us: Tvardi Therapeutics is a clinical stage, private biotechnology company developing a new class of breakthrough medicines for diverse cancers, chronic informatory diseases, and fibrotic diseases. Founded in 2017 and based in Sugar Land, TX, the company is led by experienced entrepreneurs, innovative scientists, and dedicated physicians. For more information visit: www.tvarditherapeutics.com

Position Summary: The Clinical Project Manager (CPM) is responsible for managing the operational life-cycle activities of assigned clinical programs. As an individual contributor this role is responsible for providing guidance that aligns with the principles and standard practices for operational activities of clinical trials. Together with the Tvardi Clinical Operations (ClinOps) team, the CPM will partner with key stakeholders (internal/external) to ensure alignment with ClinOps related activities and to maintain high program standards in a cross-functional environment. This position reports to the VP, Clinical Operations.

Specific Responsibilities

Project Management:

  • Closely and transparently manages the critical path of assigned projects on time and on budget
  • Represents ClinOps on cross-functional study teams and during vendor (e.g., CRO) operational meetings, and ensures compliance with operational standards and procedures
  • Provides oversight for ClinOps related issues and informs senior management of potential risks and solutions for mitigation
  • Assists in the daily management of project-specific vendors (e.g., CRO)
  • Creates meeting agendas, writes minutes, and maintains action item trackers
  • Tracks, maintains, and reports timeline and budget variances through dashboards and other status reporting tools
  • Generates weekly status reports for all on-going activities
  • Creates and oversees adherence to study plans for all operational activities associated with clinical trials
  • Ensures that all components of the electronic trial master file (eTMF) are up to date and accurate
  • Manages site feasibility and participates in site selection
  • Reviews and monitors assigned studies for billing and cost reporting compliance
  • Participates in review and approval of regulatory packet prior to site activation
  • Participates in the lifecycle management of IND documents, including annual reports, and amendments as required
  • Accountable for reviewing study budgets and master ICF templates for study start-up
  • Works with sites/internal ClinOps team/CRO to support patient recruitment and retention strategies
  • Participates in the oversight of vendor and CRO management of clinical trial material, including but not limited to; drug substance, lab collection kits, and biologic material (e.g. tissues and blood samples)
  • Participates in CRF design
  • Ensures the consistency in the collection, processing, and evaluation of clinical data
  • Ensures that the clinical trial data management team is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill regulations
  • Creates and maintains project timelines and tracking progress against goals; ensures that supporting vendor (e.g., CRO) timelines support overall project timeline
  • Proactively identifies resource constraints, risks and conflicts that could impact project timelines and collaborates with teams to develop appropriate solutions
  • Participates in the conduct of audits and supports regulatory inspections related to GCP
  • Ensures that all team members are fully informed and knowledgeable of project activities and status; optimizes communication within and between teams
  • Ensures that consistent project management tools and practices are used across teams
  • Utilizes defined guidelines and checklists, supports the coordination, oversight, and tracking of clinical research studies, and ensures clinical activity receives appropriate regulatory approvals and is conducted in compliance with the protocol and OHRP, ICH/GCP guidelines, FDA regulations, and all applicable regulatory requirements
  • Develops contingency plans to quickly and efficiently adapt to challenges that may arise
  • Identifies root causes of issues to prevent in future projects
  • Be able to successfully work with other Tvardi team members in projects spanning multiple stages of development

Corporate:

  • Contributes to the development of Standard Operating Procedures (SOPs) and company policies to ensure compliance with regional regulatory requirements and drive continuous improvements
  • Initiates and develops new and more efficient processes and procedures to meet business needs
  • Contributes to the development of presentations for executive and leadership meetings; prepare metrics/dashboards
  • Assists with the development, review and modification of clinical trial templates and documents such as lab/biopsy manuals and pharmacy manuals
  • Supports continuous improvement efforts in project management practices; leads department initiatives

Competencies:

  • Strong interpersonal and influencing skills, including the ability to negotiate effectively
  • Highly organized, excellent writing and oral communication skills, motivated and analytically rigorous
  • Adept at skillfully managing complex and challenging situations
  • Successful experience in a fast-paced entrepreneurial environment
  • Ability to prioritize multiple tasks and projects effectively within a fast-pasted, high stress environment with an ability to quickly adapt to changing program needs
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Passionate about Tvardi's mission

Qualifications:

  • Bachelor's degree in a life or physical science, pharmacy or nursing field preferred
  • PMP certification highly desired
  • Minimum of 5 years of direct functional area experience in R&D or commercial within pharma and/or biotech preferred
  • Minimum of 5 years of project management experience supporting highly matrixed drug development comprised of, but not limited to, functional area representatives from research, CMC, regulatory, clinical, and finance
  • Solid understanding of activities critical to early and late-stage drug development projects; commercial-stage a plus
  • Excellent meeting planning and facilitation skills
  • Ability to build and maintain tracking systems, spreadsheets and tools that support a systematic and scalable approach to managing projects and maintaining timelines
  • Experienced at partnering with team members to determine planning assumptions that drive timelines and budgets
  • Management of CRO activity or experience working within a CRO in a project management capacity
  • Proven track record of managing budgets
  • Well-versed in different EDC Systems, proficiency in Medidata RAVE a requirement
Tvardi Therapeutics, Inc.
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