- Data Sciences brings people, processes, and technologies together in support of Company's clinical trials. Our wide range of accountabilities span both clinical and operational domains and include development of clinical systems and management of clinical data, operations and end-user support for both clinical and operational technologies, clinical and operational data analytics, and bio-sample logistics and management.
- Provide program-level leadership and promote operational excellence ensuring successful execution of Data and Statistical Science (DSS) deliverables.
- Accountable for execution and on-time delivery of planned DSS milestones for clinical technologies from start-up through close-out
- Drive DSS study team operations and connect with cross-functional study teams to deliver trials and programs.
- Develop and sustain strong relationships between internal stakeholders, external vendors, cross-functional peers, and DSS senior management
- Synchronize deliverables between DSS, offshore resources, and vendors to deliver outcomes as planned
- Influential in setting the strategy for Data Sciences (DS)
- Management of operations through metrics. Categories include, but are not limited to, data, systems, general operations, and milestones
- Reports into the Director Clinical Data Sciences and has accountability for global study planning and execution.
location: South San Francisco, California
job type: Contract
salary: $95.00 - 102.06 per hour
work hours: 9 to 5
- Responsible for program/compound-level timelines, while ensuring compliance and quality.
- Responsible for the oversight of risk mitigation/risk management and contingency plans at a program level for all DSS deliverables
- Influence and participate in clinical strategy team; including but not limited to protocol development and clinical technologies
- Set expectations with the DSS team, the clinical study team, DS vendors, TA, and other external teams regarding timelines, processes and general coordination of the program
- Communicate with confidence and leadership with these groups for prioritizations, actions, and resolutions throughout the life of a program
- Act as a point of escalation for internal and external issues
- Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to DSS operational activities
- Oversee all Data Sciences timelines and metrics for assigned clinical trials
- Lead DSS-related cross-functional meetings with clinical teams, safety teams and physicians
- Oversee all vendor contracts for assigned clinical trials including accountability for Statement of Work (SoW) and Change in Scope
- Participate in DSS-related cross-functional meetings with stakeholders as appropriate
- Ensure stakeholder confidence in the health of the study by leading meetings to effectively communicate expectations, progress, issues and resolution
- Partner with Total Quality Management Lead to ensure highest quality of team deliverables
- Participate in any FDA or other regulatory meetings regarding assigned clinical trials
- Influence decisions and approaches through effective negotiation
- Ensure quality assurance as a measure to achieve audit and database lock readiness for assigned clinical trials and programs
- Accountable for any audit findings regarding process execution or data integrity for any assigned clinical trial.
- Mentor team members.
- Accountable for supporting and utilizing Data Sciences policies and procedures
- Bachelor's (Master's preferred) degree in business, management information systems, computer science, life sciences or equivalent.
- 5 to 8 years of direct clinical development experience. 2+ years of clinical development management. Phase II and III experience.
- Demonstrated strong leadership competencies with broad business orientation and experience in leading teams in the management and completion of clinical trials.
- Proven track record of successful studies (delivered on time, within budget, and with high quality).
- Recognized leader in process development (SOPs, Global Regulations, OEC, Outsourcing) and the application of procedures to the business. Recognized as a leader and key contributor to initiatives and advancement of DSS as an organization.
- Knowledgeable in the end-to-end clinical systems development cycle.
- Demonstrated effective communication skills.
- Ability to develop advanced knowledge of major concepts of key systems.
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Creates a learning environment, opens to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality.
- Learns fast, grasps the 'essence' and can change the course quickly where indicated. Raises the bar and is never satisfied with the status quo
skills: Phase II, Phase iii, Clinical Data Management
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.