Sr Clinical Data Associate

The Sr Clinical Data Associate is responsible for providing operational and logistical support to one or more Natera clinical trials/studies or initiative projects -Serves as a subject matter expert on technical matters and Natera procedures -Provides coaching and support to CTA/CRAs

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) and
• 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
• This role works with PHI on a regular basis both in paper and electronic form and has an access to various technologies to access PHI (paper and electronic) in order to perform the job.
• 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.

Central Lab Data Management Responsibilities

• 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

Data Management Responsibilities for Outsourced Studies

• 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 3 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.
• Full proficiency in clinical research, biosample management logistics, or data management is required (role specific
• 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.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Duties typically performed in an office setting.
• This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.
• Duties may require working outside normal working hours (evenings & weekends) at times.
• Remote position may be considered based on experience and qualifications.

No   ☒  or Yes   ☐ :  If yes state anticipated percent for travel:

OUR OPPORTUNITY