Sr. Clinical Data Manager

Primary Duties

This role will be accountable to deliver clinical data management activities across multiple clinical trials, ensuring timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.

This role will manage the coordination of activities across biometrics, clinical operations and other business partners to ensure cohesive support to clinical trial data collection, documentation, review, and reporting.

Responsibilities

Provides a high level of expertise in data management to supportclinical studies, including leading the following processes: Case Report Form (CRF) design, database design, data management plan creation and update, data validation and review plans, query resolution, data transfers and reconciliation, SAE reconciliation, medical coding, and database lock. Gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data, includingensuring adherence to defined standards. Conduct or participate in user acceptance testing to ensure high quality Perform data review and updates to document on an ongoing basis to ensure inspection readiness at all times. Ensure medical coding has been performed and appropriate reporting of data for medical and safety reviews are occurring. Ensuring effective quality oversight and management of external partners (e. g. Function Service Providers, CROs, technology providers,etc.)performing data management services on behalf of Spark Manage time and resource constraints across multiple projects. Provide weekly status reporting related to data collection, cleaning progress and database lock process Participate in departmental initiatives, as requested. Participate in vendor evaluation and selection efforts. Contribute to SOP development and updates. Other duties as assigned

Education and Experience Requirements

Bachelor’s degree required with an advanced degree preferred. Generally, has 5+ years of clinical data management experience with a minimum of 2 years of demonstrated experience leading projects with increasing levels of responsibility and a thorough understanding of the processes associated with data management and reporting. Experience in rare disease or a therapeutic area of interest to Spark (e.g. hematology, immunology, neurology) is not mandatory but preferred. Familiarity with SAS and Spotfire preferred. Thorough knowledge of the pharmaceutical industry and regulations applicable to data management responsibilities.

Key Skills, Abilities, and Competencies

Strong written and verbal communication skills. Competency in industry leading clinical platforms (e.g. Medidata Rave, Oracle) and well versed in industry trends and emerging technologies supporting data collection. Solid understanding of CDISC standards used in database design (e.g. CDASH). Understanding of medical coding dictionary structures (e.g. MedDRA, WHODrug).

#LI-JW1

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

Nearest Major Market: Philadelphia

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 challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

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