Orbis Clinical is seeking a remote-based Senior Clinical Data Manager for 12 months.

Client is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

The Opportunity (12-month contract / eligible for renewal )

In anticipation of the Company’s growth plans, Client is seeking to recruit a Senior Clinical Data Manager (CDM) Contractor. The Senior CDM Contractor will work in an outsourced data management model. He or she will develop strategy, lead data management activities and will interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner. This individual will also independently perform / oversee tasks related to database and report setup, as well as processing and cleaning clinical trial data, following all applicable standard and study-specific procedures.

Responsibilities (include but are not limited to the following):

Primary

• Serve as a data management expert and, if assigned, be the CDM Lead for assigned clinical studies on multidisciplinary project teams.
• Deliver high quality data for analysis and study milestones.

Other Responsibilities

• Review protocols from a CDM perspective and provide functional-expert feedback
• Review and approve key clinical data management deliverables generated by a DM vendor, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements
• Manage / oversee study setup, testing and system validation for new studies in partnership with the DM vendor
• Oversee data cleaning activities executed by the DM vendor and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data
• Collaborate with internal Data Science (statistical programming), internal Biostatistics, and internal Medical Monitor on identifying critical variables in the clinical dataset, for protocol-specified endpoints. Coordinate implementing these variables into DM vendor activities
• Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management vendor and client project team
• Monitor vendor performance to ensure timelines and data quality standards are met
• Ensure compliance of clinical data management processes with applicable regulations and guidelines

Requirements

• Typically requires a Bachelor's degree in mathematics, science, or a health-related field and a minimum of 10 years of clinical data management experience in biotech, pharmaceutical, or health-related industries
• Demonstrated proficiency leading CDM deliverables across Phase 1–3 clinical trials, including early-phase and dose-escalation studies
• Solid understanding of the clinical drug development process and regulatory/data standards (ICH/FDA, CDISC - CDASH, SDTM, ADaM - GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, GDPR)
• Demonstrated understanding of the clinical trial database life cycle, including CRF design, development/testing, discrepancy management, data quality review, and database lock
• Capable of proactively identifying project risks and proposing strategic solutions; excellent multi-disciplinary interpersonal and communication skills
• Strong analytical and problem-solving skills; able to work independently and within cross-functional project teams

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $80-$85 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.