Logo of Huzzle

Home

Matches

Explore

Manage

Clinical Trial Manager

image

Denali Therapeutics

6d ago

  • Job
    Full-time
    Mid & Senior Level
  • Research & Development
    Healthcare
  • South San Francisco
  • Quick Apply

AI generated summary

  • You need a Bachelor's degree, 4+ years in pharma with 2+ years in trial management, strong organizational and communication skills, and the ability to manage priorities and solve problems.
  • You will manage study operations, ensure compliance with GCP/ICH, oversee vendors, conduct feasibility assessments, train staff, review budgets, and maintain study quality and documentation.

Requirements

  • Bachelor’s degree required. RN/PA with professional clinical experience, and/or Master’s degree or higher in health-related science or equivalent preferred.
  • 4+ years in a pharmaceutical setting (sponsor side experience a plus) with 2+ years of trial management experience required.
  • Excellent organizational skills and attention to detail.
  • Effective communication and interpersonal skills.
  • Ability to efficiently perform multiple tasks and manage changing priorities.
  • Ability to identify and solve logistical problems.
  • Ability to build strong relationships with co-workers of various backgrounds and expertise.
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.

Responsibilities

  • Lead/support: internal cross-functional study execution team for assigned stud(ies) and/or assigned stud(ies); preparation of vendor requirements and project scope and selection of study vendors.
  • Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes managing clinical research organizations to ensure timely and quality deliverables.
  • Lead/support feasibility assessment and selection of countries and sites for study conduct, development of study plans, system set-up and UAT to ensure operational excellence of protocol, CRF, CSR and other key study deliverables.
  • Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
  • Oversee the quality of the clinical trial master files as well as the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
  • Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals).
  • Ensure set-up and implementation of effective investigator and site monitor training, create and conduct study-specific training at investigator meetings.
  • Review study invoices and participate in accrual reviews to track the financial status of the study against budget.
  • Ensure that all work adheres to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.

FAQs

What are the primary responsibilities of a Clinical Trial Manager at Denali Therapeutics?

The primary responsibilities include leading cross-functional study execution teams, managing day-to-day operations of assigned studies, overseeing vendor management, ensuring compliance with GCP/ICH guidelines, developing study plans, and maintaining clinical study files.

What qualifications are required for this position?

A Bachelor’s degree is required, with a preference for an RN/PA with professional clinical experience, or a Master’s degree or higher in a health-related science. A minimum of 4 years of experience in a pharmaceutical setting, including 2 years of trial management experience, is required.

Is experience on the sponsor side important for this role?

While not mandatory, experience on the sponsor side is considered a plus for this position.

What skills are emphasized for this role?

Key skills include excellent organizational abilities, attention to detail, effective communication and interpersonal skills, problem-solving capabilities, and the ability to manage changing priorities and relationships with diverse co-workers.

What is the salary range for the Clinical Trial Manager position?

The salary range for this position is between $136,000.00 to $157,000.00, depending on the candidate’s qualifications, skills, competencies, and experience.

Does Denali Therapeutics offer benefits for this role?

Yes, Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, an Employee Stock Purchase Plan (ESPP), and a broad range of other benefits.

What is the working environment like at Denali Therapeutics?

Denali Therapeutics fosters a diverse and inclusive environment and is committed to its core company value of unity. Employees are encouraged to collaborate and build strong relationships within a team setting.

Are there opportunities for professional development in this role?

Yes, opportunities for professional development are available, including training at investigator meetings and participation in data reviews, which contribute to continued learning and growth in the field.

Denali Therapeutics

Defeat Degeneration

Science & Healthcare
Industry
201-500
Employees
2015
Founded Year

Mission & Purpose

Denali Therapeutics is dedicated to defeating neurodegenerative diseases by breaking through historical barriers in scientific research and clinical development in order to deliver safe and effective medicines to patients and families. Our scientific approach is based on three core principles: rigorous assessment of genetic targets, engineering brain delivery, and using biomarkers to guide development. Our team thrives in a work environment that is scientifically driven, impact-focused, supportive, and collaborative. Our ability to have a positive impact on people’s lives is directly related to the trust we have in each other and our ability to unify our diverse backgrounds and experience behind our purpose to defeat degeneration.