Principal Clinical Data Manager
Redwood City, California
Expiry Date :
Thu, 08 Apr 2021 23:59:59 GMT
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Principal Clinical Data Manager Job Locations US-CA-Redwood City Req No. 2021-7162 Category Business Analytics Type Regular Full-Time Summary of Major Responsibilities The Principal Clinical Data Manager is responsible for ensuring the accurate, complete, and timely collection, delivery, and management of assay/genomic and clinical data for analysis, reporting, and presentation. The Principal Clinical Data Manager acts as Lead Data Manager on complex to highly complex clinical studies and projects; either independently or by directing others, provides expert Clinical Data Management functional representation to study teams. Remote work option is available for this role. Essential Duties and Responsibilities Specify, configure, and maintain novel or complex clinical study databases and related tools; including, but not limited to, screen design, edit check development, query management, data extraction, and data management related reporting. – Maintain knowledge and understanding of current team, department, and corporate-goals and priorities to ensure effective time management and focus; assist in developing department and functional team goals. – Execute software development lifecycle practices; including requirements definition, risk assessment, and programming validation; provide backup to CDO management for lifecycle document approval, as requested. – Exhibit consistent compliance with established department and company processes, procedures, guidelines, and best practices. – Train others on complex to highly complex company processes, procedures, guidelines, and best practices, as required. – Prepare and maintain complex documentation, as required, by established departmental procedures, practices, or project-specific needs. – Review documentation of peers to ensure compliance with established standards. – Interact with Exact Sciences study team members, collaborators, vendors, or partners to gather or define complex to highly complex requirements, plan deliverables, and communicate progress and findings. – Train clinical site personnel and collaborators on the effective use of study-specific data management tools. – Contribute to the ongoing development and improvement of department procedures by being the primary author of complex to highly complex process documents and by effectively and actively contributing to or leading process discussions. – Lead CDO teams or cross-functional teams with well-defined objectives or interactively lead teams to establish objectives on assigned initiatives and special projects; as needed, directly manage staff. – Provide appropriate support and coordinate with other functional areas regarding overall clinical study conduct and management; including protocol development, study start-up, study closeout, and data analysis. – Utilize expert knowledge of industry data management processes and procedures to effectively lead highly complex data management projects and assignments. – Programmatically combine and manipulate highly complex electronic data from a variety of sources. – Create specifications and work closely with Clinical Data Programming to build highly complex Electronic Data Capture (EDC) study databases; including edit checks and dynamic entry screens. – Lead the planning and execution of User Acceptance Testing (UAT) for assigned EDC study databases; perform all documentation activities as specified by company and department procedures; serve as senior reviewer of UATs performed by other Data Managers, as requested. – Participate in recruiting and hiring of staff. – Mentor coworkers; take project-level supervisory responsibilities for large-scale projects. – Ability to work as the lead clinical data manager on the department’s most complex projects. – Excellent oral and written communication and presentation skills. – Excellent organization skills and detail orientation. – Ability to work closely and effectively in a team-oriented environment with colleagues from Biostatistics, Non-clinical biostatistics, Clinical Operations, Regulatory Affairs, Medical, Pathology, and Program Management to ensure Data Management needs and status updates are addressed and well-communicated. – Ability to deliver quality results in a timely manner, either independently or by directing others. – Ability to work effectively with coworkers and external contacts. – Excellent negotiation and conflict resolution skills. – Ability to be highly effective in a fast-paced, rapid growth environment. – Ability to receive and apply feedback in a professional manner; ability to convey both positive and constructive feedback to others in a professional and effective manner. – Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. – Support and comply with the company’s Quality Management System policies and procedures. – Regular and reliable attendance. – Ability to lift up to 10 pounds for approximately 5% of a typical working day. – Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day. – Ability and means to travel between Redwood City locations. – Ability to travel 10% of working time away from work location, may include overnight/weekend travel. Qualifications Minimum Qualifications – Bachelor’s degree in Life Sciences, Scientific based field, or related field. – 10+ years of experience in data management or a related field as outlined in the essential duties. – Expert knowledge of relational database concepts and operation; demonstrated ability to filter and manipulate data using complex SQL queries and SAS data steps. – Expert professional knowledge of industry Data Management processes, procedures, and best practices. – Expert professional knowledge of Electronic Data Capture (EDC) system; including edit checks programming and dynamic entry screen specification. – Demonstrated ability to use Excel and other tools for data filtering and sorting. – Proficient in Microsoft Office suite. – Demonstrated ability to perform the Essential Duties of the position with or without accommodation. – Authorization to work in the United States without sponsorship. Preferred Qualifications – Relevant post-graduate degree. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.