Senior Clinical Data Coordinator
South San Francisco, CA 94080
Bayside Solutions is seeking a Senior Clinical Data Coordinator to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Senior Clinical Data Coordinator:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Responsible for the production of non-CRF data collection specification documentation.
- Defines the study specific non-CRF data handling strategy.
- Collaborates with SMT to agree on vendor expectations for the collection and transfer of data.
- Reviews and refines the technical requirements with service provider to establish the transfer of non-CRF data.
- Responsible for establishing appropriate transfer methodology with external data provider.
- Provides transfer methodology training and documentation on non-CRF data for external vendors.
- Responsible for configuring the data loading tools based on data collection specifications.
- Receives, uploads, confirms and communicates status of test data transfers to validate and accept file format and database structure.
- Performs verification and resolves data transmission, file format and loading errors with data providers.
- Proactively checks all inbound non-CRF electronic data for any potentially un-blinding data as defined in the protocol and ensures study integrity by sequestering un-blinding data until data release is authorized.
- Delivers data to external recipients and review bodies via established transfer methodologies.
- Represent CDM on IxRS sub teams and works with the Study Management Team to develop IxRS specifications and implement the system.
- Coordinates and plans sub-function activities to meet program-level deliverables and timelines.
- Develops and maintains the sub-function standards for the studies in a program.
- Collaborates with Data Modeling Specialists to define study data collection standards for new assessments and collaborates with them to implement new standards.
- Effectively communicates ideas, project goals and status of work and can present to senior management.
- Proactively develops solutions to complex problems requiring the regular use of ingenuity and innovation.
- Sets targeted timeframes for deliverables and anticipates potential scenarios that may result in timeline delays; able to influence and negotiate a positive outcome.
- Proactively develops contingency plans to reduce impact of risks that may occur, to analyze effectiveness of strategies and to monitor and review risks.
Summary of Qualifications:
- Requires a B.A./B.S. or equivalent with significant experience in one or more Clinical Data Management, Biometrics or relevant clinical development functions.
- Knowledge of core clinical data management applications (Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite).
- Clinical data management system experience (EDC Medidata Rave preferred).
- Ability to apply advanced principles, theories and concepts for CDM as a whole.
- Understanding of the conceptual basis for data management conventions, standards and processes.
- Good understanding of the role of data management, biostatistics and statistical programming in the drug development process.
- Ability to develop solutions to complex problems.
- Ability to grasp industry trends and apply them to work within the organization.
- Ability to multi-task and effectively set own priorities.
- Strong organizational skills.
- Strong communication and interpersonal skills.