BioSpace, Inc.
Manager, Data Management Science
BioSpace, Inc., San Rafael, California, United States, 94911
Job Details
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.
Clinical Study Development and Execution 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 Cross-Functional Leadership
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 Subject Matter Expertise
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.
EQUIPMENT
Computer work utilizes common business software programs and hardware solutions.
CONTACTS
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.
Company
At BioMarin, we translate the promise of genetic discovery into medicines that make a profound impact on the life of each patient.
Since our founding in 1997, we've developed a proven track record of innovation with eight commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, we seek to unleash the full potential of genetic science by pursuing category-defining medicines that offer new possibilities for people living with genetically defined conditions around the world.
As we have looked to expand our impact, our approach to cutting-edge science has remained the same. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science.
Company info Website https://www.biomarin.com/ Location San Rafael and Novato California United States
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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.
Clinical Study Development and Execution 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 Cross-Functional Leadership
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 Subject Matter Expertise
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.
EQUIPMENT
Computer work utilizes common business software programs and hardware solutions.
CONTACTS
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.
Company
At BioMarin, we translate the promise of genetic discovery into medicines that make a profound impact on the life of each patient.
Since our founding in 1997, we've developed a proven track record of innovation with eight commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, we seek to unleash the full potential of genetic science by pursuing category-defining medicines that offer new possibilities for people living with genetically defined conditions around the world.
As we have looked to expand our impact, our approach to cutting-edge science has remained the same. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science.
Company info Website https://www.biomarin.com/ Location San Rafael and Novato California United States
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