Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA. Our mission is to bring innovation to clinical trial execution through passion, transparency, co-active communication, and integrity, to facilitate the successful development of life-changing medicines and therapies.
We are experts in clinical trial operations with a focus on Clinical Trial Management, CRO/Vendor Oversight, Trial Master File Management, Clinical Monitoring, Quality Assurance, Data Management and Study Startup. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering integrity forms the foundation for our strong relationships both internally and as a partner to our Sponsor clients. Beginning with study development, we bring a “white glove service” approach to clinical trials.
Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients’ needs as they evolve.Our talented team is driven by passion and purpose, which has afforded us the opportunity to successfully lead clinical programs for pharmaceutical, medical device and biotechnology companies of all sizes in a variety of therapeutic areas. Our mission is to conduct clinical trials with outstanding quality on behalf of our clients to bring new drugs to market with the utmost integrity and confidence in the results.Position Overview:This is an exciting opportunity to join a young and lively company in a fast-paced and dynamic environment.The Clinical Data Specialist (CDS) will be responsible for project assigned tasks under direction of the Lead Data Manager and/or Director of Clinical Data Management; Ensuring clinical data review activities are conducted in an effective efficient manner and in accordance with Standard Operating Procedures (SOPs), regulatory directives; and study specific plans.Essential Duties & Responsibilities:
- The Clinical Data Specialist (CDS) will be responsible for clinical data review as assigned.
- The review tasks performed by this role include both point-to-point clinical data checks and interpretive analysis such as reviewing data for submission, highlighting errors, raising queries etc.
- Ensures data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications.
- Provide support as required to address data related issues internally.
- Attends Clinical Meetings and Study Meetings, as necessary.
- Participate in User Acceptance Testing to ensure accuracy of CRFs, custom functions and edit checks, as applicable.
- Performs data cleaning to identify data trends.
- May Participate in data review meetings.
- Review and query clinical trial data according to the Data Management Plan.
- Perform External Data Reconciliations.
- Review listing for data review based on the guidance provided by the sponsor and/or Director of Data Management.
- Provide support to audit and inspection and management to address issues identified during data review.
- Run patient and study level status and metric reports.
- Perform SAE/AE reconciliations.
- Other duties as assigned.
Experience & Skills:
- 2 years or more experience in Clinical Data Review in either a CRO/or pharmaceutical or biotech industry or equivalent relevant experience and or demonstrated competencies / Senior CDR Level: 4 years or more experience in Clinical Data Review in either a CRO/or pharmaceutical or biotech industry.
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
- Able to handle a variety of clinical research tasks.
- Excellent organizational and communication skills.
- Professional use of the English language; both written and oral.
- Experience in utilizing various clinical database management systems.
- Ability to travel domestically and internationally with overnight stays.
- Ability to work independently, manage time and create plans to achieve personnel goals.
- Ability to work effectively with minimal direction; must be a self-motivated and self-directed individual who enjoys a challenging anddynamic work environment.
- Team player willing to collaborate and share knowledge.
- Highly organized.
- Effective communication skills.
- Excellent organization and prioritization skills.
Education:Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred. Other bachelor's degrees with relevant industry experience will be considered.Compensation Range:Clinical Data Reviewer:$80,000 - 100,000 annually + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)Senior Clinical Data Reviewer: $90,000 - 115,000 annually + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)COVID-19 Vaccination: To protect the health and safety of our employees and to comply with client requirements, Vanguard Clinical may require employees in certain positions to be fully vaccinated against COVID-19, subject to reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.
Vaccination requirements will depend on the client site requirements. Proof of vaccination may be required, in accordance with applicable laws.Vanguard Clinical is an equal opportunity employer for all applicants and employees. Vanguard Clinical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
