Senior Clinical Data Associate

POSITION SUMMARY:

The Senior Clinical Data Associate is responsible for providing clinical data management support for clinical studies that support the development, validation, and commercialization of non-invasive molecular diagnostic tests.   

PRIMARY RESPONSIBILITIES:

• Supports clinical data management activities across clinical studies managed by the Clinical Operations department

• Supports development and maintenance of all CDM related SOPs, Work Instructions

• Supports strategic initiatives for the clinical data management function

• Maintain standardized processes for data management activities

• Represent clinical data management in cross-functional meetings

• Reviews trial protocols and assists in the planning and implementation of the Clinical Data Management process.

• Participate in study document reviews (e.g., clinical study protocols, statistical analysis plans)

• Work cross-functionally with other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting

• Responsible for oversight of data transfers for assigned studies

• Participate as needed in the preparation and presentation of data.

• Ensure accurate development and execution of data integrations between databases such as EDC, LIMS, and other internal and external data sources

• Ensure data system compliance by following the established guidelines (e.g. FDA).

• Performs other duties as assigned

• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

• Must maintain a current status on Natera training requirements.

• Employee must pass post offer criminal background check. Central Lab Data Support prospective sample data management for studies where Natera functions as a central testing facility

• Contribute to the end-to-end data workflow and database integration logistics

• Work cross-functionally with engineering and IT departments to develop study specific reports, dashboards, and database requirements Data Management Responsibilities for In-House Studies EDC development and maintenance, including database programming

• Responsible for ensuring complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans

• Ensure completeness, accuracy, and consistency of clinical data and data structure Responsible for CRO oversight of data management activities

• Contribute to CRF Design and data management strategy

• Serve as the primary liaison between internal stakeholders and the CRO with respect to study data requirements

QUALIFICATIONS:

• Bachelor’s degree in data science, other relevant discipline, or equivalent required. Advanced degree preferred.

• Minimum of 5 years of experience in managing EDC for medical device, in-vitro diagnostic device trials, and/or laboratory data management. 

• Certificate in clinical data management preferred but not required. 

• Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, human subjects protection, and GCP.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Familiar with the FDA regulations relevant to clinical trials and EDC.

• Proficiency in Microsoft Office and Google Suite platforms.

• Good organization and planning skills.

• Strong interpersonal skills and communication skills (both written and oral).

• Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment.

• Ability to collaborate with the study team, cross functional team members and external collaborators.

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$92,200—$115,300 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthi