Sr. Clinical Data Manager

Clinical --> Biostatistics and Data Management

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.

This is life-changing work, and we are all in, are you?

Job Summary

The Sr. Clinical Data Manager will handle detailed data management issues for all phases of clinical trials (Phase 1-3) including oversight of CRO data management activities and, as needed/requested, provide support to other functional areas within Akebia. The Sr. Clinical Data Manager will be recognized as a leader by their project team.

Essential Functions & Duties

• Contribute to the decision-making process involving data management (DM) issues for large or complex clinical studies. Communicate how DM decisions impact other functional areas and the company as a whole
• Provide oversight and participate in study setup and initiation procedures such as CRF design, database design, edit check design/review, DMP (Data Management Plan) review/approval and annotated CRF design; this may include the performance of user acceptance testing.
• Ensure completeness and accuracy of all study documentation, may include the need to perform eTMF quality checks. Coordinate and participate in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy
• Address/respond to data issues, as needed, identified by cross-functional team members
• Apply experience and education to initiate and develop new and more efficient processes and procedures for study setup, maintenance, closure and archiving activities to meet business needs
• Develop and implement changes to DM guidelines and quality processes to ensure clinical databases, external data files and analysis datasets are designed in a standard, accurate, complete and consistent format conducive to analysis and regulatory submissions by working with lead CRO data manager or equivalent
• Develop/utilize study metrics to monitor quality, project status, activities and budget and work with Manager to identify trends and provide updates/recommendations to Sr. Management on opportunities for improvements; For some studies, this may include the generation, review and/or follow up, as needed, on study level operational performance and quality metrics
• Assist in the coordination of the acquisition and development of tools to support data management tasks internally and externally with DM vendors; this may include development of specifications, validation documentation or perform validation.
• Ensure that optimal relationships are developed with internal customers/colleagues and with new or existing strategic partners/vendors

Skills & Experience

Minimum Basic Qualifications

• BA/BS in a scientific discipline
• 7+ years of experience (with at least 4 years as lead) as a Data Manager in a CRO or pharmaceutical/biologics/biotechnology company

Preferred Qualifications and Experience

• Experience as lead CDM managing studies from start-up through close-out (including data management activities related to study conduct, study completion and archiving of study materials)
• Experience in a pharmaceutical/biologics/biotechnology company must include management or oversight of outsourced CDM activities
• Comprehensive understanding of DM responsibilities and project activities (i.e. budget, timelines, resources) and of linkages with tasks and responsibilities of other functions
• Capable of prioritizing individual and CRO/Vendor tasks based on timelines and study needs
• Ability to use metrics to determine project status, monitor internal/external DM team progress and plan for project resources and monitor project budget
• Ability to communicate data management standards, developments, and challenges in an accurate, concise, consistent, organized and grammatically/situationally correct manner to both internal and external audiences
• Ability to propose areas for development or process improvement and assist with staff compliance
• Ability to apply technical knowledge to work activities and use critical thinking skills for problem identification and solving
• A demonstrated proficiency in efficient database and/or SAS dataset design
• Familiarity with ICH GCP as well as full knowledge of industry practices and standards (CDISC, SDTM, CDASH)
• Ability to prioritize and effectively manage several large projects simultaneously
• Capacity to work with little or no supervision with accuracy and thoroughness
• Excellent written and oral communication skills

Compensation:

Targeted Base: $167,774 - $207,251

*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Are you an Akebian?

An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com

Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristics protected by applicable law.