POSITION SUMMARY:

The Senior Manager of Clinical Data Management is responsible for providing leadership in the Clinical Data Management function for clinical studies across Natera’s portfolio. The Senior Manager of clinical Data Management will both contribute to, and directly manage a team of 2-7 Clinical Data Managers and/or Clinical Data Associates, to support all aspects of clinical trial data management leading to the development, validation, and commercialization of best in-class assays

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PRIMARY RESPONSIBILITIES:

• Manage a team of 2 -7 Clinical Data Managers and Specialists who perform Clinical Data Management tasks across studies in Women Health, Organ Health, Early Cancer Detection and Oncology or Clinical Trail Services Studies.

• 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, Data Transfer Specification (DTS) ...etc).

• Lead and support the team in developing clinical trial data specifications, including eCRF design, user requirements, edit checks, query logic and data validation, and site training for EDC where applicable.

• Be accountable for the quality and integrity of the clinical data within Natera’s EDC and/or LIMS 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.

• Performs other duties as assigned.

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.

• 7 years minimum experience with roles of increasing responsibility in Clinical Data Management.

• At least 2 years of people management experience.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Solid knowledge of FDA regulations relevant to clinical trials and clinical trials software platforms, such as EDCs, and eConsent.

• Proficiency in Google Workspace (gSuite), MS Word, Excel and PowerPoint.

• 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 are 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 and weekends) at times.