Cancer has no borders. Neither do we.

Senior Director, Global Clinical Operations, Study Start-Up

Clinical OperationsClinical OperationsFull TimeRemoteTeam 10,001+Since 2010H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

53 days ago

Salary

$206.2K - $276.2K / year

Bachelor Degree12 yrs expEnglishGoogle Cloud Platform

Job Description

• Lead the strategic planning and execution of study start-up activities across clinical programs, ensuring rapid, high-quality site activation. • Provide leadership to cross-functional teams, oversee budgets, engage key stakeholders, and drive continuous process improvements. • Develop and implement activation strategies, manage regulatory and ethics submissions (IRB/EC and Health Authorities), oversee site contract and budget negotiations. • Monitor operational KPIs, ensure audit and inspection readiness, and lead end-to-end study start-up activities. • Drive continuous improvement initiatives focused on reducing activation timelines and increasing predictability, and evaluate and introduce innovative tools. • Champion change management related to new systems, SOPs, and operational models.

Job Requirements

Bachelor’s degree in a life sciences discipline required; advanced degree preferred.
At least 12 years of clinical research experience, with 6 years in clinical operations leadership roles in sponsor/biotech/CRO settings.
Proven track record of operational excellence in delivering clinical trials, ideally including innovative approaches to speed up study start-up and site activation.
Extensive experience as a direct line manager with responsibility for performance management and team development.
Expert knowledge of global clinical trial regulations (ICH-GCP, FDA, local regional authorities).
Strong expertise in global study start-up processes—including clinical trial package preparation, submissions, contracting, and site activation.
Advanced risk management and problem-solving abilities.
Strong financial acumen including budget forecasting and cost oversight.
Ability to work independently and manage multiple priorities effectively.

Benefits

Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Annual bonus plan
Incentive compensation plan
Employee Stock Purchase Plan

Related Categories

Clinical Operations

Related Job Pages

Remote Full-time Jobs (US)More US Remote Jobs

More Clinical Operations Jobs

Associate Clinical Project Manager

LivaNova

Improving Quality of Life Through Innovation. Every Patient, Every Day

Clinical Operations53 days ago

Full TimeRemoteTeam 1,001-5,000H1B Sponsor

Company Site LinkedIn

Associate Clinical Project Manager assisting with clinical study management at LivaNova

Google Cloud Platform

View details: Associate Clinical Project Manager

Colorado + 2 more

$95K - $105K / year

Apply

Executive Director – Global Clinical Operations

Apogee Therapeutics

Clinical Operations53 days ago

Full TimeRemoteTeam 51-200H1B No Sponsor

Company Site LinkedIn

Executive Director leading global clinical operations at a biotech company

Google Cloud Platform

View details: Executive Director – Global Clinical Operations

United States

$285K - $320K / year

Apply

Manager, Clinical Operations

NAMSA

Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes. Learn more: https://namsa.com/about/client-testimonials

Clinical Operations53 days ago