Edgewise Therapeutics

Develops therapies for rare muscular disorders

Clinical Trial Manager/ Senior Manager

Clinical Research OperationsConfirmed live in the last 24 hours

Full-time

About the Job

Requirements

A B.S. or B.A. in nursing, a scientific field, or a business-related field.
At least 7 years of clinical operations experience in clinical trial design and conduct, including at least 5 years of industry experience.
In-depth knowledge of clinical research operations, including Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations, and International Council for Harmonisation (ICH) guidelines.
Proficiency in Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS).
Experience with Phase 2 and Phase 3 studies that are globally recruited.

Responsibilities

Provide operational expertise and strategic input for assigned clinical studies.
Develop and manage study budgets, including site payment management and vendor invoicing.
Participate in country and site feasibility and selection, providing country insights, corporate agreement, and therapeutic expertise to align the study execution plan with program strategy.
Provide strategic input and manage site activation activities and recruitment strategies.
Oversee study timelines to ensure clinical development plan requirements are met.
Participate in vendor evaluation and selection; support site or vendor audits with Research and Development Quality Assurance, including resolution of findings; serve as the assigned department representative for clinical vendor relationships and management as applicable.
Oversee strategic partner, contract research organization, and vendor selection, budgeting, contract negotiation, and performance guidance for assigned studies, escalating issues to management or governance committees when warranted.
Oversee or execute site selection and start-up activities for assigned studies, including essential document review, creating or reviewing Site Qualification Visit and Site Initiation Visit decks, participating in those visits, and collaborating with the contracts team to execute clinical trial agreements and amendments promptly.
Oversee assigned Edgewise Clinical Research Associates as applicable; oversee and approve monitoring documents, plans, and activities; periodically review outputs and monitoring-related actions; and perform or attend monitoring visits as needed to represent the sponsor.
Develop, review, and approve relevant study plans as applicable.
Manage and attend study team meetings and regularly review meeting agendas and minutes.
Oversee the protocol deviation process for assigned studies, including reviewing individual deviations, categorizing them, and identifying trends across sites or the study to inform actions.
Review study-level risks and decisions and implement mitigation strategies.
Partner with data management to review and pressure-test database timelines and plans; link filing, registration, and data-generation strategy with tactical plans for database lock and the clinical study report; participate in electronic data capture system user acceptance testing; proactively review the system to identify issues; and participate in data review and assist internal and external team members with data-related queries and requests.
Participate in developing Interactive Response Technology systems by reviewing specifications and conducting user acceptance testing with Clinical Supply and Statistics.
Oversee and support Trial Master File activities as required.
Participate in monthly Safety and Compliance meetings by reviewing adverse events, drug accountability, and protocol deviations.
Contribute to drafting Standard Operating Procedures and follow department and study-specific processes to keep studies inspection-ready; prepare for and attend regulatory inspections as needed.
Support onboarding, mentor, and manage direct reports within the department.
Collaborate with other functional leads on project-related efforts and participate in departmental quality or process-improvement initiatives.
Read, understand, and comply with workplace health and safety policies, safe work practices, and company policies and procedures.
Perform other duties as assigned by the supervisor.

Desired Qualifications

Experience in more than one therapeutic area is advantageous.
Experience in rare or orphan diseases and cardiac experience are a plus.

At Edgewise, we are focused on advancing novel, muscle-targeted therapeutics for serious cardiovascular and cardiometabolic conditions with significant unmet need. Leveraging our expertise in muscle biology and small molecule drug development, we are building a cardiovascular pipeline that includes programs for hypertrophic cardiomyopathy, heart failure and other serious cardiovascular diseases.

We’re building a passionate, experienced team committed to tackling complex scientific and clinical challenges and delivering meaningful outcomes for patients. If you’re looking to do work that matters, we’d love to hear from you.

About the Position:

Edgewise is headquartered in Boulder, Colorado and this is an on-site (preferred) or remote position for a growing Clinical Operations team. The assigned clinical studies will be highly complex and high risk, e.g., multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidate may be asked to lead/provide oversight for more than one study or across programs and be assigned direct report(s).

Essential Job Duties and Functions:

Provide operational expertise and strategic input for assigned clinical studies.
Development and management of the study budget inclusive of site payment management and vendor invoicing.
Participate in country and site feasibility/selection process, with a focus on providing country insights, corporate agreement, and therapeutic expertise to ensure understanding between study execution plan and program strategy.
Provide strategic input and management of site activation activities and recruitment strategies.
Oversight of study timelines to ensure the needs of the clinical development plan are met.
Participate in vendor evaluation and selection activities. In conjunction with Research & Development QA support site and/or vendor audits including resolution of findings. Assigned Department Representative responsible for Clinical Vendor relationship and management as applicable.
Oversee strategic partners/CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities assigned to a strategic partner/CRO/vendor for assigned studies, including escalation of issues to management and/or governance committees when warranted.
Oversight/execution of site selection and start-up activities as needed for assigned clinical studies (e.g. essential document review, Site Qualification Visit (SQV) and Site Initiation Visit (SIV) deck creation/review, participate in SQV/SIV, collaborate with contracts team to ensure timely execution of CTAs and Amendments as applicable)
Oversight of Edgewise CRAs assigned to clinical studies as applicable. Oversight/Approval of monitoring documents/plans and activities, including periodic review of outputs and actions related to monitoring. Perform or attend monitoring visits as needed for Sponsor representation.
Development, review and approval of relevant study plans, as applicable.
Study team meeting management and attendance; regular review of meeting agendas and minutes.
Oversight of protocol deviation process for assigned study including review of individual protocol deviations, categorization and actions; primary purpose of review is to help identify trends across sites or the study.
Review and monitoring of risks and decisions at the study level and implementation of mitigation strategies.
In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between the strategy (i.e., filing/registration, data generation) with the tactical plan for database lock and CSR. Participate in electronic data capture (EDC) system UAT. Proactively review EDC to identify issues. Participate in data review and assist internal/external team members with data-related queries/requests.
Participate in the development of IRT systems through reviewing system specifications and UAT in collaboration with Clinical Supply and Statistics.
Oversight and support of TMF activities as required.
Participate in monthly Safety and Compliance meetings by reviewing adverse events, drug accountability and protocol deviations.
Contribute to drafting Standard Operating Procedures (SOPs) and adhere to department and study-specific processes to ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections.
Support onboarding, mentor and manage direct reports within the department.
May collaborate with other functional leads to manage project related efforts. Participate in departmental quality or process improvement initiatives.
Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
Perform other duties as assigned by supervisor.

Required Education, Experience and Skills:

B.S./B.A. in nursing, scientific or business-related field
7+ years of clinical operations experience in clinical trial design and conduct; 5+ years industry experience
In-depth knowledge of clinical research operations, including GCP, FDA regulations, and ICH guidelines
Proficiency in Electronic Data Capture and Clinical Trial Management Systems
Experience must include Phase 2 and 3 studies (globally recruited).
Experience in more than one therapeutic area is advantageous. Rare/Orphan disease and cardiac experience is a plus.
Excellence in project management and communication.

Salary range: $130,000 - $180,000, title and salary commensurate with experience

Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.

Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.

About the Company

Edgewise Therapeutics

Develops therapies for rare muscular disorders

Edgewise Therapeutics develops therapies for rare muscle disorders using a proprietary drug discovery platform. Its lead molecule, sevasemten (EDG 5506), targets the muscle motor protein myosin to reduce stress in fast skeletal muscle fibers, aiming to improve muscle health without affecting other muscle types. The company owns global development and commercialization rights to its programs and pursues strategic collaborations and asset acquisitions to accelerate its pipeline. Its focus is precision medicine for conditions like Duchenne muscular dystrophy, Becker muscular dystrophy, Limb Girdle muscular dystrophies, and McArdle disease. Overall, Edgewise seeks to deliver targeted treatments that protect and improve muscle health for patients and families affected by these rare diseases.

Company size: 51-200
Company stage: IPO
Headquarters: Boulder, CO
Founded: 2017

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