Align Technology · 3 hours ago
Clinical Project Manager
San Jose, CA
Full-time
Onsite
Senior Level
$132K/yr - $181K/yr
6+ years expAlign Technology is looking for an experienced Clinical Project Manager to join their Global Clinical Affairs team. The role involves leading and managing clinical projects to ensure studies are executed according to regulations and quality standards, while coordinating with cross-functional teams and external stakeholders.
HardwareHealth CareManufacturing
Responsibilities
Define project scope, develop timelines and budgets, and assemble the study team clinical affairs activities (including but not limited to clinical studies, limited releases, focus groups, data collection activities, etc)
Ensure the trial adheres to all regulations (e.g., ICH-GCP, FDA, EMA) and maintain high-quality data collection and documentation
Oversee the study budget, manage expenses, and ensure necessary resources are available for the project
Coordinate cross-functional teams, lead the project team, and manage relationships with external vendors like Contract Research Organizations (CROs)
Independently assess and determine the most efficient methods for conducting the study and collaborations needed with internal and external stakeholders, utilizing a variety of strategies and tools to ensure the study stays on track
Act as the primary point of contact for stakeholders, providing regular status reports and facilitating communication between teams and sponsors
Oversee all aspects of the trial, from site activation and participant enrollment to data monitoring and final reporting
Identify and think critically to resolve issues that may arise to ensure the study (and the Clinical Affairs team) stays on track
Ensure the team performs evaluations of potential investigational sites and investigators for participation in clinical trials (or limited releases)
Is accountable for perform auditing of investigational sites and investigators to ensure data integrity and protocol compliance
Assist Clinical Research team with negotiating and obtaining approval for investigator agreements
Lead in the education, training and support of investigators and their staff prior to and during clinical trials of investigational devices (or limited releases of approved products)
Lead the effort in development of clinical protocols, case report forms, informed consent forms, investigator manuals, product instructions for use, and study training materials
Prepare and finalize clinical documents for IRB submission and obtain IRB approvals
Prepare clinical trial language details and post on clinicaltrials.gov (as applicable)
Lead team in the interactions with sites and data management team to resolve data queries and to ensure data integrity and completeness
Person must have excellent organizational skills and pay extreme attention to detail
Person must have excellent interpersonal and oral/written communication skills and be able to work independently
Other duties may be assigned
Provides technical assistance to study sites regarding the conduct of clinical research
Track data report forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites
Oversees delivery and shipment of aligners for clinical studies
Assists in writing annual and final clinical study reports
Ensures accurate, up-to-date records of all documents and protocols of all clinical studies
Follows all departmental and company procedures as indicated in quality, administrative, or other systems
Ensures the effective fulfillment of objectives and deadlines assigned to the group
Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources
Participate in proactive team efforts to achieve departmental and company goals
Travel may be required – up to 25%
Perform other duties as assigned
Qualification
Required
Bachelor of Science, or equivalent experience, required
Experience running clinical studies from a project management perspective required
Person must have excellent organizational skills and pay extreme attention to detail
Person must have excellent interpersonal and oral/written communication skills and be able to work independently
Ability to think critically and scientifically
Ability to give presentations and updates on clinical research/studies
Ability to write clinical reports and protocols
Ability to communicate effectively
Has a proactive mindset and strong drive to take initiative, actively seek opportunities and solutions
Has a go-getter attitude to take on challenges with determination and strives to deliver quality results
Teamwork: Ability to work both independently and collaboratively
Preferred
Masters of Science preferred
6-10 years' experience in clinical research industry preferred
2-5 years' experience as Senior Clinical Research Associate
Dental industry experience preferred
Experience with SaMD clinical studies is preferred
Person must have familiarity with applicable FDA regulations
Benefits
Family Benefits. Align offers employees and their eligible dependents medical (with a Health Savings Account option for some plan offerings), dental, and vision in accordance with those plans.
Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment
Back-up Child/Elder Care and access to a caregiving concierge
Family Forming Benefits – Available to Employees, and their spouse or domestic partner, covered under one of Align’s health plans
Breast Milk Delivery and Lactation Support Services
Employee Assistance Program
Hinge Health Virtual Physical Therapy – Available to all employees and eligible dependents (age 18+) enrolled in an Align medical Plan
Short-term and long-term disability insurance in accordance with those plans.
Basic Life Insurance and Accidental Death and Dismemberment.
Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) are available for purchase in accordance with those plans.
Flexible Spending Accounts – Employees may be eligible to participate in a health care account (including a limited health FSA if enrolled in a HDHP), dependent care account, and a pre-tax commuter benefit plan.
401k plan (with a discretionary Company match of 50% up to 6% of eligible earnings up to a maximum match of 3%.). Employer match vests after two years – 25% year one and 100% at year two. Align offers traditional, Roth, and after-tax options.
Employee Stock Purchase Program (Employees must work 20 hours or more and be employed on purchase date to be eligible).
Paid vacation of up to 17 days during the first full year of employment (currently accrued at the rate of 5.24 hours each pay-period), which carries over to a maximum cap of 30 days.
Sick time is accrued throughout the year at the rate of one hour for every thirty worked.
11 Company-designated paid holidays throughout the year.
If employed for at least 12 consecutive months, Align will grant up to 6 weeks of paid Parental Leave.
Three days of paid bereavement leave.
Non-exempt employees will receive full pay for up to 10 days of jury duty.
Company
Align Technology
Align Technology, Inc. designs, manufactures, and markets the invisalign system for treating malocclusion or the misalignment of teeth.
10001+ employees
H1B Sponsorship
Align Technology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (75)
2024 (57)
2023 (49)
2022 (60)
2021 (66)
2020 (31)
Funding
Current Stage
Public CompanyTotal Funding
$136MKey Investors
QuestMark PartnersComdisco Ventures
2001-01-26IPO
2000-06-21Series D· $105M
1999-10-07Series Unknown· $26M
Leadership Team
Joseph Hogan
CEO, President, and Director
Ben Park
Head, Emerging Technology | Research & Development
Recent News
2026-01-21
Company data provided by crunchbase