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At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm’s employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.
About This Role
We are seeking an experienced Senior Clinical Data Manager to lead the data management activities for clinical trials and ensure high-quality, accurate, and timely delivery of clinical data. The Senior Clinical Data Manager will be responsible for developing and implementing data management plans, supervising the work of junior data management staff, collaborating with cross-functional teams, and providing technical expertise in all aspects of clinical data management. The successful candidate will have extensive experience in clinical data management, strong leadership skills, and a deep understanding of regulatory requirements and guidelines.
Key Responsibilities:
- Lead the development and implementation of data management plans, including data validation, cleaning, and quality control procedures.
- Supervise the work of junior data management staff, providing training, guidance, and mentoring as needed.
- Collaborate with cross-functional teams, including biostatisticians, clinical operations staff, and medical monitors, to ensure the timely and high-quality delivery of clinical data.
- Provide technical expertise in all aspects of clinical data management, including database design, EDC systems, and data standards.
- Develop and maintain study databases and data management tools, ensuring they are compliant with regulatory requirements and guidelines.
- Participate in the development of case report forms (CRFs), data validation plans, and data transfer agreements.
- Review and resolve data queries, perform data cleaning and quality control procedures, and ensure the accuracy and completeness of study data.
- Participate in the development of clinical study reports (CSRs) and other study-related documents.
- Stay up-to-date with advances in clinical data management, EDC systems, and regulatory requirements and guidelines.
Qualifications:
- Bachelor's or Master's degree in a related field (e.g. life sciences, computer science).
- At least 7 years of experience in clinical data management, including experience with EDC systems and data standards.
- Strong knowledge of clinical trial operations and regulatory requirements and guidelines (e.g., FDA, ICH, GCP), preferably in medical devices.
- Strong proficiency in data management software, such as Medrio, Veeva, Medidata Rave, Oracle Inform, or OpenClinica.
- Excellent leadership, communication, and interpersonal skills, with the ability to work effectively in a team environment.
- Attention to detail and ability to manage multiple tasks simultaneously.
- Strong problem-solving and critical thinking skills.
- Experience with CDISC standards and data standardization is a plus.
- Experience with data visualization and analytics tools is a plus.
What's In It For You
This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer:
- emotional health support for you and your loved ones
- legal / financial / identity theft/ pet and child referral assistance
- paid parental leave, paid holidays, travel assistance for personal trips and PTO!
iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of Linked In Learning classes and so much more!
FLSA Status: Exempt
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Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.
iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com
About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.
Make iRhythm your path forward. Zio, the heart monitor that changed the game.