Assoc Dir, Clinical Data Mgmt at Natera

, , United States -

Full Time

Start Date

Immediate

Expiry Date

01 Jan, 26

Salary

175800.0

Posted On

03 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Team Management, EDC Implementation, Data Management SOPs, Clinical Trial Data Specifications, eCRF Design, Data Validation, Statistical Review, Data Analysis, HIPAA Compliance, Data Literacy, Professional Development, Recruitment, Thought Leadership, Quality Assurance, Training

Industry

Biotechnology Research

Description

PRIMARY RESPONSIBILITIES: ● Manage a team of 2 - 5 Clinical Data Managers, Managers, and/or Sr. Managers who perform Clinical Data Management tasks across studies in Women Health, Organ Health, and Oncology. ● Responsible for building an effective team, including identifying, recruiting, and vetting Clinical Data Manager candidates, and for their professional development. ● Be a thought leader in the Clinical Data Management domain as it applies to Natera’s unique studies. ● Oversee and be accountable for the efficient and compliant performance of standard Clinical Data Management tasks, including but not limited to the implementation of EDC, developing and maintaining Data Management SOPs and related documents (Data Management Plan, Data Review Plan...etc), developing clinical trial data specifications, including eCRF design, user requirements, edit checks, query logic and data validation, and site training for EDC. ● Be accountable for the quality and integrity of the clinical data within Natera’s EDC system and applicable data sources, ensuring it is in a fit state to quality to lock/unlock and freeze/unfreeze as appropriate for statistical review. ● Ensure data system compliance by following the established industry guidelines (e.g. FDA). ● Oversee and participate in the analysis, preparation and presentation of data as needed by study teams. ● Be “data literate”, exhibit the ability to interpret and give input into summary statistics and various visuals (distribution charts, bar charts) and data dashboards required by study teams. ● 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. QUALIFICATIONS: ● Bachelor’s degree required, life science background preferred, but equivalent industry experience acceptable. Advanced degree and experience in a data-driven quantitative field highly preferred. ● 12 years minimum experience with roles of increasing responsibility in Clinical Data Management. ● At least 3-5 years of people management experience. 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 $140,600—$175,800 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, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.natera.com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

Responsibilities

Manage a team of Clinical Data Managers and oversee Clinical Data Management tasks across various studies. Ensure the quality and integrity of clinical data and compliance with industry guidelines.