Sr. Clinical Research Associate/Clinical trial Manager

Openkrill; United States; Remote; USD 145,000 - 177,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program

Hybrid work model

Job summary

You will contribute to master file maintenance, creation of regulatory documents, and investigator meetings while adhering to ICH E6(R3) standards. The role requires travel to meet study needs and to support global trials.

Qualifications

• Bachelor’s degree in a scientific or medical field.
• 4–6 years of clinical study experience in biotech or pharmaceutical sponsor organizations.
• Experience supporting global studies in a fast-paced environment.
• Vendor management experience in Clinical Operations.
• Excellent communication skills and ability to work in a remote environment.
• Working knowledge of ICH E6(R3) GCP principles.
• Proficiency with MS Office and SmartSheet.

Responsibilities

• Collaborate with Clinical Operations to support studies from planning through close-out.
• Lead regional site initiation activities, monitor performance, mitigate risks, and drive action items.
• Oversee CROs and other vendors, set expectations, and ensure deliverables.
• Review monitoring documentation and oversee monitor/site performance.
• Contribute to development and maintenance of study documents and regulatory submissions.
• Ensure the Trial Master File is complete and inspection-ready.
• Apply ICH E6(R3) GCP and risk-based quality management practices.
• Travel up to 20% as required.
• Support Investigator Meetings and cross-functional study discussions.

Skills

Vendor management

Communication

Remote collaboration

Global studies experience

Project coordination

Quality mindset

GCP knowledge

Education

Bachelor’s degree in scientific/medical field

Tools

MS Office Suite

SmartSheet

Job description

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read onIn 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allowsscience and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

Company Overview

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 20+ drug development programs spanning preclinical to late-stage development across multiple therapeutic areas.

QED Therapeutics, an affiliate of BridgeBio Pharma, is dedicated to developing targeted treatments for FGFR-driven skeletal dysplasia, focusing on Achondroplasia (ACH) and Hypochondroplasia (HCH). Achondroplasia is the most common form of genetically driven short stature, and Hypochondroplasia is a genetic condition that affects the way bones grow; both conditions can lead to significant medical complications throughout life. With our investigational therapeutic candidate, infigratinib, we seek to deliver meaningful treatment options that address the underlying cause of these conditions and improve outcomes for children and families living with ACH and HCH.

What You’ll Do

As a Sr. Clinical Research Associate/Clinical Trial Manager, you will collaborate within the Clinical Operations team to support the timely conduct of clinical studies according to protocols, GCP, SOPs, and applicable regulations. You will be responsible for performing quality study oversight processes, including monitoring communications with site staff and clinical vendors, and reviewing monitoring trip reports.

• Partner with the Clinical Operations Study Lead and cross‑functional team to support clinical studies from planning and start‑up through execution, maintenance, and close‑out in accordance with assigned SOPs, ICH/GCP, and corporate and departmental goals.
• Lead operational management for assigned regions and sites by driving site initiation activities, monitoring performance metrics, identifying and mitigating risks, driving escalations and action‑item closure, and representing regional performance in study team and cross‑functional discussions.
• Lead aspects of vendor management for the CRO and other key vendors (IRT, imaging, central and specialty labs, etc.), establishing expectations, ensuring deliverables are met, performance measures are maintained, and escalating as needed; address performance gaps and drive corrective actions to closure.
• Provide oversight of CRO monitors by reviewing monitoring documentation, evaluating monitor and site performance, conducting oversight or co‑monitoring visits as needed, and identifying cross‑site or systemic risks.
• Contribute to the development and maintenance of study documents, including informed consent forms, site training materials, CRFs, monitoring plans, source document templates, protocols, investigator brochures, and regulatory submission materials under the direction of the study lead.
• Ensure the Trial Master File is complete, current, accurate, and inspection‑ready, and drive resolution of missing or deficient documentation.
• Apply ICH E6(R3) Good Clinical Practice principles, including quality by design, risk‑proportionate oversight, critical‑to‑quality factors, participant protection, and reliable trial results, across study activities.
• Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and drug questions, safety, regulatory, and legal questions.
• Participates in the review and negotiation of site budgets and contracts.
• Support and participate in Investigator Meetings and other study‑related meetings, as required.
• Promote a collaborative, respectful, quality‑focused work environment.
• Additional Clinical Operations activities may be assigned as appropriate.
• Travel as required to carry out responsibilities (up to 20%).

Where You'll Work

• This is a U.S.-based remote role that will require quarterly or as‑needed visits to our San Francisco Office.

Who You Are

• Hold a bachelor’s degree or equivalent training and experience (i.e., RN/PA, BSN degree) in a scientific or medical field.
• Minimum 4-6 years of clinical study experience, preferably within biotechnology or pharmaceutical sponsor organization.
• Experience supporting global studies in a fast‑paced environment.
• Success in working with CROs and vendors; Must have vendor management experience in Clinical Operations.
• Excellent communication skills and ability to achieve milestones in a team environment.
• Ability to communicate and collaborate respectfully in a remote environment.
• Ability to build and maintain strong working relationships within the department, cross‑functionally, with clinical sites, vendors, and CROs to meet a project or corporate goal.
• Working knowledge of ICH E6(R3) Good Clinical Practice principles and risk‑based quality management.
• Experience using M.S. Office Suite (Excel, Word, PowerPoint) and SmartSheet

At BridgeBio, we strive to provide a market‑competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi‑state employer, and this salary range may not reflect positions based in other states.

Salary$145,000-$177,000 USD

As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

Financial & Rewards

• Market‑leading compensation
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre‑tax commuter benefits (transit and parking)
• Referral bonus for hired candidates
• Subsidized lunch and parking on in‑office days

Health & Well-Being

• 100% employer‑paid medical, dental, and vision premiums for you and your dependents
• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
• Fertility & family‑forming benefits
• Expanded mental health support (therapy and coaching resources)
• Hybrid work model with flexibility
• Flexible, “take‑what‑you‑need” paid time off and company‑paid holidays
• Comprehensive paid medical and parental leave to care for yourself and your family

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via Linked