Manager, Data Management Science

Manager, Data Management Science

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. BioMarin aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care, and providing personalized support and services globally.

BioMarin Global Data Science (GDS) is responsible for designing, capturing, analyzing, and presenting data that can drive key decisions for Clinical Development, Medical Affairs, and other business areas of BioMarin. With a quality-by-design culture, GDS builds quality data that is fit-for-purpose to support statistically sound investigation of critical scientific questions. The GDS team develops solid analytics that are visually relevant and impactful in supporting key data-driven decisions across BioMarin.

The GDS Data Management Science (DMS) group contributes to Global Data Science by providing complete, correct, and consistent analyzable data at data, data structure and documentation levels following international standards and GCP. The GDS DMS Operations sub-function is responsible for the efficient and effective delivery of complete, correct, and consistently fit-for-purpose data sets for statistical analysis across all clinical development and post-approval programs. The team brings a focus on process improvement through innovation and the application of best practices to the oversight and execution of all program-related data management activities such as Protocol review, Case Report Form (eCRF) development, Data Management Plan development, Data Validation Plan development, requirement specifications, reconciliations, and data validation activities to ensure data integrity and data quality.

The DMS Operations Manager role is a Study Lead role on multiple Clinical Studies. The Manager participates in all study-related data management activities, including Protocol review, eCRF development, Data Management Plan development, Data Validation Plan development, reconciliations, and delivery of complete, correct, and consistently fit-for-purpose study datasets for statistical analysis. The DMS Operations Manager may also act as Process Improvement / Departmental Initiative contributor, as needed.

Key Responsibilities :

DMS Operations Manager may participate in all, or part of the following activities as delegated by the GDS Data Management Science Operations Program Lead :

• Complete all study Data Management activities and deliverables, including (but not limited to) : Ensure Data Management colleagues and GDS colleagues are engaged in study startup activities by facilitating appropriate project management activities, such as kick-off meetings, timelines, other relevant communications; Conduct protocol review and raise any data collection considerations affecting data quality, reliability, or suitability for statistical analysis; Define Case Report Form (eCRF) in concise, self-explanatory, and user-friendly format. Collaborate with study team colleagues to ensure eCRF completion guidelines / instruction are accurate; Develop and facilitate approval of Data Management Plan outlining key data management activities and deliverables; Collaborate with Clinical Programming and Data Quality Science and facilitate the completion of the Data Validation Plan; Collaborate with Clinical Programming and Database Development colleagues to ensure that database build occurs in accordance with specifications and timelines; Execute appropriate ongoing / periodic Data Validation activities in collaboration with Clinical Programming, including reviews of data listings, discrepancies, and the related follow-up on management of queries with investigators; Conduct the identification, investigation, and resolution and / or escalation of study and program data issues, as appropriate; Oversee and facilitate medical coding activities; Collaborate with Clinical Programming on the development and execution of data transfer specifications; Collaborate with Clinical Programming and Global Patient Safety (GPS) on SAE reconciliation activities; Complete pre-database lock or snapshot checklist activities and related Data Validation meetings with cross-functional stakeholders to approve the DB lock / snapshot go ahead
• Develop and deliver regular updates to leadership on key program risks, issues, and milestones
• Oversee Trial Master File update for all Data Management deliverables
• Ensure compliance with Regulatory Guidelines (e.g. FDA, ICH) across all study-related Data Management activities
• Represent Data Management as a member of the relevant study team (e.g., Clinical Study Execution Team (SET) or Post-Approval Medical Affairs Program Team (MAPT) or Study Team (MAST)); Lead Data Working Group to investigate, diagnose, and resolve study data issues; lead the cross-functional review of data management deliverables : CRF, edit checks, DM plan; Lead all data collection and management-focused meetings with cross-functional partners / stakeholders : Data Science colleagues, GSO, GMAF, GCD, GPS, Translational Science, Project Management, Compliance, and Regulatory; Participate in Data Analysis and Review Team (DART), when appropriate, to discuss Data Management deliverables and activities
• Participate in initiatives aimed at expanding Global Data Science and Data Management Science capability in a designated area of expertise, such as CDISC / CDASH, central labs, local labs, Artificial Intelligence (AI), ePRO, imaging, RWE, Risked Based Quality Management (RBQM), etc. by building best practices in processes, tools, templates, or other guidance for the subject area.

Competencies :

Decision Making, Critical thinking and Problem Solving, such as skill in the ability to gather data and input, using multiple sources if applicable, to develop holistic understanding of problems and propose comprehensive solutions. Influence, Cross-Functional Collaboration and Organizational Awareness, by seeking opportunities to interact with peers and stakeholders; builds a network of internal and external peers. Agility and Proactivity, by being able to demonstrate resourcefulness to find, and resolve to be comprehensive in obtaining, information needed for complete and timely closeout of tasks and deliverables. Leadership, such as skill in clearly communicating objectives, goals, and expectations to others. Emerging understanding of study team roles and responsibilities and how they contribute to overall priorities; recognizes opportunities to improve study deliverables to support the organization. Communication, including an ability to respond promptly to stakeholders, peers, and management with clear and organized messages and ensures that important information is shared in a timely manner. Strategic Thinking and Planning, such as an ability to focus on performance measurement to track progress toward objectives. Operations, such as being able to demonstrate basic understanding of how programming supports study execution phases; ask questions and seek guidance to clarify understanding and priorities. Experienced with clinical data programming and able to review and evaluate clinical data. Communicates design / specifications in an unambiguous manner and adjusts communication as per context. General data management science skills, such as the development of comprehensive data validation plans in accordance with standards / SOPs; consistently approaches data validation and data quality planning with a focus on process improvement. Understands the objectives / purpose of each drug development phase (I-IV) and the related key cross-functional deliverables. Demonstrates basic knowledge of relevant products(s), the disease / condition that the product(s) treat, mechanism of action, efficacy, safety profile, and development status. Familiar with key medical coding terms and reporting formats; able to review and identify potential issues based on coding.

Career Development

BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for GDS Data Management Science has been defined and is available to employees of BioMarin.

People Management

The DMS Operations Manager role is primarily an individual contributor role and will not require consistent people management.

Education and Experience

BA / BS degree with a focus in data science, statistics, computer science, life science, or related scientific discipline 3+ years of experience in clinical development, including technical experience within and outside of Data Management with MS; 6+ years with BS

Work Environment / Physical Demands / Travel

The employee may frequently be required to sit and talk or listen. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and / or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

Computer work utilizes common business software programs and hardware solutions.

This position will interact with a range of personnel across the BioMarin organization, including but not limited to other Global Data Science and Data Management Science personnel.