Senior Clinical Data Programmer Relevant Educational Qualifications Job1 week ago - Other categories - Houston - 25 views
Veeva Vault Clinical Data Management System (CDMS) is changing the way clinical data is managed in the industry. Vault CDMS combines EDC, coding, data cleaning and reporting into one application. Gone are the days of complex integrations that limit clinical data availability, now research teams can make faster and more informed decisions.
Veeva Systems is looking for Senior Consultants who have deep data management expertise and are experienced in helping customers optimize the use of EDC in running their clinical trials. Strong EDC design and configuration experience (eCRF's, Edit Checks, etc). Designing forms and rules in EDC is one facet of the required skill set but also understanding how data is managed, cleaned and reported is equally important. We're looking for EDC design and configuration specialists that also fully understand clinical data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH). Perhaps your current role has only focused on configuration or data management experience, here at Veeva, we realize the importance of both in one role.
As a key member of our CDMS Professional Services team, the Senior Consultant will be at the forefront of our mission and responsible for four main things:
Understanding customers' data management needs and challenges, offer guidance and direction to ensure that the clinical trial is designed with the deliverable in view.
Understand our customers' clinical trial, protocol requirements to implement a study design with the Vault CDMS application adhering to Good Clinical Data Management Practices and Veeva standards to optimize value.
Responsible for authoring all specification documents used by team members and configuring the study design during the development phase of the project.
Train and mentor customers and clinical sites who are working with the Vault CDMS application or are new to clinical trials.
What You'll Do
- Review and finalize all project specifications applying industry and Veeva best practices
- Engage with existing Vault CDMS customers or potential customers in pre-sales phases on their data management challenges and determine how Vault CDMS can alleviate current obstacles.
- Participate in Vault CDMS Product team discussions to convey data management activities, challenges, and end- user expectations.
- Share data management experiences and educate fellow Vault CDMS team members on CDM standards and guidelines.
- Attend appropriate CDM conferences and/or customer data management on-site discussions as deemed necessary.
- Configure Veeva products during development
- Support developers and testers during the project lifecycle
- Support the requirements gathering and specification creation process for all study integrations
- Conduct on-site or remote user acceptance testing with the customer including coordination of all feedback, resolution of issues and acceptance of the study
- Support go-live activities for the study to ensure a smooth transition of the study to the customer
- Review requirements as part of the change management process and update specifications and configurations as necessary with associated scoping activities
- Support services pre-sales activities including review of customer requirements and scoping
- Act as the customers trusted advisor to ensure that the study trial design is configured in such a way that it meets the customer's goals and offers the full benefits of Veeva's CDMS application
- Notify project management of project risks and develop contingency plans as necessary
- Ensure customer success from beginning to end of the project life cycle
- Assure process compliance with all regulatory and Veeva procedural requirements
- Participate and contribute to process product or best practices initiatives
- Adherence to all Veeva and CDMS Services procedures and policies
- 5+ years of experience in end to end data management related activities (database design, data collection, data analysis, query resolution, datasets, statistical reporting)
- Strong understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH).
- Experience in working with customers to build libraries and define data standards for use in their clinical studies.
- 5+ years of direct experience working with EDC clinical software solutions in clinical operations, and/or trial management in a project management/consultant role
- Life sciences industry experience and knowledge of clinical trial process preferred (pharmaceutical, biotech, medical device companies, CRO's and academic & public health organizations).
- Experience in interpreting clinical protocols and translating requirements into software specifications including writing and reviewing technical documentation
- Experience in a customer-facing role, preferably with a software professional services organization or consulting background is preferred
- Working Knowledge of Clinical Trial processes across pharmaceuticals, device and/or biotech sectors, specifically as they relate to design, document, and data collection
- Ability and willingness to "roll up your sleeves" to implement a clinical solution
- Ability to quickly understand business requirements
- Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a team
- Logical approach to problem-solving
- Ability to manage multiple tasks and project deliverables
- Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results
- Demonstrated success with customers during project assessment, planning, development, training, and implementation.
- Excellent verbal and written communication, interpersonal, and presentation skills
- Expert on life sciences compliance and computer systems validation requirements
- Ability to travel 25-30% (may include international)
- 4-year college degree required
- Qualified candidates must be legally authorized to be employed in the United States. Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Nice to Have
- Hands on data management experience.
- Active CDM society memberships (ie, CCDM(R)).
- Direct experience with EDC systems.
- Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, and other clinical technologies
- Life Science, computer science or related degree
- Familiarity with CDISC, ODM and other data management industry standards
- SaaS/Cloud experience in the delivery of clinical trials
- Enterprise experience and knowledge transfer for running clinical trials with EDC
- Experience with training for clinical sites and at investigator meetings
- Consulting experience
This is a work anywhere, full time permanent role with Veeva. Our work processes are designed so that you can be productive in the environment that works best for you. This is a customer facing role and we have no work location requirement if you are in close proximity to an airport and able to meet future travel requirements.
Perks & Benefits
- Flexible PTO
- Allocations for continuous learning & development
- Health & wellness programs
Veeva's headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.