[Hiring] Senior Specialist, Clinical Research @Edwards Lifesciences LLC
Mar 26, 2025 - Edwards Lifesciences LLC is hiring a remote Senior Specialist, Clinical Research. 💸 Salary: $106,000 to $149,000. 📍Location: USA.
Role Description
This role involves ensuring clinical trials are conducted and reported in accordance with all applicable regulatory requirements.
- Execution of study start-up and study conduct activities including ICF review, developing study specific templates and TMF plan, approving and managing study specific essential documents, managing and communicating the status of study progress and activities, and driving resolution of issues encountered with sites during all phases of the study.
- Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution.
- Lead the investigation of all discrepancies identified in study documentation reconciliation by applying clinical protocol requirements, GCP knowledge, Edwards SOPs, and appropriate regulations and guidance.
- Develop and implement processes to mitigate reoccurrence of issues throughout the study.
- Lead in assessing current and new processes, identifying and implementing solutions to improve process efficiency within and across related functional areas.
- Conduct in-house and site (if applicable) reviews of associated documentation and lead in internal and competent authority (e.g., FDA, DEKRA, ANVISA) audits to ensure documents are compliant with Good Documentation Practices and Edwards internal SOPs, and US and OUS regulations.
- Provide coaching and knowledge transfer to team members.
- Prepare materials for meetings (Steering Committee, Investigators, etc.).
- Other incidental duties.
Qualifications
- Bachelor's Degree in related field.
- 5 years' experience with regulatory documentation for clinical studies.
- Experience and expertise in site monitoring, site qualification, and site training.
- Able to travel to EU, lead/attend meetings in different time zones.
Requirements
- US East Coast location (home based).
- Cardiac research exposure/experience.
- Sponsor experience with clinical trial operations/research.
- Medical device trial knowledge/experience.
- Experience working with teams outside of the United States.
- Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file).
- Full knowledge and understanding of policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols.
- Full understanding of regulatory submissions, reporting, and audits; understanding of international and domestic medical device regulations and guidance.
- Excellent written and verbal communication skills and interpersonal relationship skills.
- Excellent problem-solving and critical thinking skills.
- Ability to interact professionally with all organizational levels.
- Ability to manage confidential information with discretion.
- Strict attention to detail.
- Ability to manage competing priorities in a fast-paced environment.
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
Benefits
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
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Salary
💸
$106,000 to $149,000
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Mar 26, 2025
|
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
