Clinical Project Manager

Clinical Project Manager

Department: Research & Development

Employment Type: Full Time

Location: US-California-San Jose

Description

This position is ideal for experienced and detail-oriented professionals who are interested in joining the Global Clinical Affairs team as a Clinical Project Manager. Partnering with cross-functional teams (such as R&D, Marketing, etc), as well as internal and external customers, you'll help lead and manage projects to ensure clinical studies and activities are executed in accordance with applicable regulations and that the quality of clinical data generated from clinical trials or limited release meets the regulatory requirements for approval. The CPM may also assist other departments to execute post marketing studies of approved products either to comply with regulatory approval conditions or to generate additional clinical information for marketing purposes. This role is responsible for ensuring that the studies are conducted in accordance with the study protocol and Good Clinical Practice. The process includes interaction and communication with key project stakeholders, clinical sites, private-practicing orthodontists, and treatment coordinators related to case specific issues, status updates, budgets and timelines related to the project.

• 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.

Additional responsibilities:

• 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.

Working Relationships:

• Internal - Position interacts on a regular basis with all members of the Regulatory Affairs, Legal, Product Innovation, Marketing and with members of other departments as a representative to internal project teams as appropriate.

• External - Position interacts with investigational site personnel including investigators, their staff, clinical and administrative personnel; contract monitors, and data management. External interaction includes Institutional Review Boards (IRB) and Contract Research Organization (CRO) for research.

Decision-Making Authority:

• This individual will make decisions together with the Clinical Affairs leadership team and will at times be required to make critical independent decisions when working with investigational sites and IRBs.

• Bachelor of Science, or equivalent experience, required

• 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 running clinical studies from a project management perspective required

• Experience with SaMD clinical studies is preferred

• Person must have familiarity with applicable FDA regulations

Skills:


o Ability to think critically and scientifically

o Ability to give presentations and updates on clinical research/studies

o Ability to write clinical reports and protocols

o Ability to communicate effectively


o Has a proactive mindset and strong drive to take initiative, actively seek opportunities and solutions


o Has a go-getter attitude to take on challenges with determination and strives to deliver quality results


Communication:

• Excellent presentation and communication skills
• Teamwork: Ability to work both independently and collaboratively

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Pay Transparency

If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate's pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically.


For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S.


Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience.

General Description of All Benefits


We are pleased to provide a general description of the benefits Align offers to full-time employees in this position.


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. Align also offers to employees:

• 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

Employee benefits. Align offers its employees:

• 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. Annual paid vacation time accrual increases based on tenure. Both exempt and non-exempt employees who work 32 hours or more per week receive prorated vacation accrual based on their regularly scheduled work hours and tenure.
• Sick time is accrued throughout the year at the rate of one hour for every thirty worked. Employees can carry over unused sick leave each year, up to a maximum balance of 80 hours.
• 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. If employed for less than 12 consecutive months, Align will grant up to 4 weeks of paid Parental Leave. All parental leave must be completed within one year of the birth or placement of the child. Parental leave is in addition to any state and/or local parental leave benefits. Three days of paid bereavement leave. In some cases, due to travel the amount of paid leave may be extended to 5 paid days off. To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
• Non-exempt employees will receive full pay for up to 10 days of jury duty. Exempt employees will receive their full salary during any week they serve and perform any work. Other insurance such as legal, critical illness, voluntary accident, long-term care, auto, home and pet insurance are available for purchase.

To the extent applicable state or local law offers more generous benefits, Align complies with any such law.