Dir, Clinical Data Management

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. 

 

We don’t follow footsteps. We create the path.

 

 

Primary Duties

Clinical Data Management (CDM) supports development and marketed products across Spark by ensuring the accurate and timely acquisition, analysis and reporting of diverse clinical data through CRF / eCRF design, editing specifications and query resolution processes. CDM also manages data transfers from vendors, such as central labs and others.

 

The Director CDM is responsible for providing strategic and operational leadership of the data management function within Development and Product Strategy (Dev & PS), enabling delivery of complete, high quality and reliable clinical trial information to enable internal decision making, regulatory approval and market acceptance. This role reports to the Head of Biometrics & RWE.

 

As a people leader, the expectation is that the Director CDM will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

 

Responsibilities

Establish and implement the clinical data strategies to deliver the timely and high quality acquisition and validation of the clinical data supporting regulatory filings, publications and other high-profile business activities across all Spark clinical trials spanning Phase 1-4.

 

Ensure effective quality oversight and management of external partners (e.g., Specialty labs, CROs, technology providers, etc.) performing data management services on behalf of Spark.  Establish and implement a quality plan defining the review strategy for each clinical trial in collaboration with various Spark stakeholders (e.g., statistics, medical, safety, clinical development, clinical operations, etc.), enhancing quality of patient data for statistical analyses and support regulatory filings, publications and other high-profile business activities.

 

Develop and implement the future vision for CDM at Spark: Data strategy, roadmap and execution plan to create an industry-leading clinical data capability, including the digitization of external data capture and acquisition.

 

• Comprehensive automation strategy to streamline data management processes and enhance operational efficiency.
• Optimize approaches that support data visualization and enhance the reviewer experience.

 

Provide leadership to the CDM team.  Coach team members on their performance, development and career interests.

 

Develop strong working relationships with key stakeholders throughout Spark, with the ability to think strategically across a broad portfolio and effectively express her/his views to senior management.

 

 

Education and Experience Requirements

• MS/BS in life sciences or related field (MS preferred)
• At least 10 years of relevant industry experience in life sciences with oversight of external partners in a global setting.
• Experience managing people is required.
• Project management certification (e.g., PMP) is a plus.

 

Key Skills, Abilities, and Competencies

• Demonstrated expertise in the management of clinical trial data is a must.  Prior experience providing data management support in gene therapy, rare disease and/or observational studies is a plus.  Working with specialty labs is highly desirable.
• Global clinical trial expertise and a successful track record of leading through influence, working across global organizational matrices.

• Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.
• Solid understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
• Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
• Well versed in industry trends and emerging technologies concerning data review.
• Exceptional interpersonal skills and understanding of team dynamics. Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution.
• Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives.

 

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position