Job Title: Safety Operational Quality Support
Job Company: Major BioPharma
Job Location: SSF, CA 94080
Job Duration: 1 year contract; Replacement
Reports to Global Process Owner – SDD/SDD Manager
Provide global oversight of Safety Document Distribution and ensure compliance to Global procedural documents. This is achieved by interfacing with functional groups in clinical operations, drug safety and regulatory, Quality, SDD vendor, IT support team and the Global Process owner.
Strive for continuous improvement through innovation, standardization and training. Achieve through collaboration with the Global process owner and functional representatives for safety document distribution.
Ensure Health of Process:
1. Ensure all country profiles are available
2. Monthly review to ensure that all sites have been "Welcomed. "
- Everyone is alerted
- All sites have registered recipient
- Inform teams of gaps
1. Serve as single point of contact for process related questions
2. Distribue one off alerts (TBD)
Archive support (TBD)
Annual CAR update (maintenance of CAR)
Monthly review of welcome pack registration to ensure all sites have delegated contacts
Quarterly Healtj Report
1. Study country trend reports
2. Trend analysis and recommendations
3. Annual health check report (process improvement)
Manage content in wiki
Accountable to communicate changes as needed
Loop back with GPO office related to metrics
Process contact for any systems forums and attend as needed
Quarterly review of IT help desk questions and provide recommendations as needed
Annual review of list of active users
- Provides global strategic direction and input for ensuring compliance to SDD to ensure Roche meets current and future business needs. (25%)
- In collaboration with GPO, Define and track key milestones and deliverables ensuring delivery on the strategy and tactics for SDD
- Develop communication plan for SDD in conjunction with the global Process owner
- Work with key internal and external partners to develop future strategies and through strong collaboration build and maintain communication networks with key external stakeholders
- Effectively represent internal and external stakeholders on oversight committees (e.g. Steering Committees, Advisory Boards, QATs) and other cross-functional working groups to ensure that the SDD procedures remains in alignment with other global procdures.
- Establish analytics and metrics to ensure SDD rpocdures will withstand regulatory scrutiny
2. Operational Support: Supports the functions to ensure compliance SDD during the clinical trial (50%)
3. CAPA Management (10%)
- User Registration review
- Transmission Support and correction
- Arriving at close out
- Manage Unblinded distributions
- CAR Governance
4. Knowledge management (15%)
- Support study teams and affiliates in preparation for Inspections and audits
- SME for questions on SDD during inspections
- Conduct root cause analysis for all major and critical findings
- CAPA Implementation lead role for SDD specific issues
- Identify Affiliate Management training needs and develop/implement training strategies/ interventions for their area of expertise in conjunction with internal and external functional and/or training groups and in alignment with other functions as required.
- Develop and execute a quality control (QC) plan to determine if end user adoption and consistent implementation of processes and procedures for their area of expertise have been achieved.
- Lead and/or participate in activities and knowledge sharing in their area of expertise to improve and maintain the quality of training and development.
- Ensure COMPANY is inspection ready related to SDD procedures
Education / Skills / Knowledge / Experience Required:
- Support Global Procedural documents and related process documents
- Manage SDD wiki
- Manage training strategy
- SME for questions and primary point of contact for issue escalation
- Minimum of four (4) year University degree preferable Life Science field
- Minimum of 5 years of experience with Global Operational teams and at least three (3) years Manager experience (preferred)
- Demonstrated high level of initiative and ability to function independently with minimal or no daily supervision.
- Expert knowledge of ICH/GCP, EMA, Global procedural documents and local regulatory requirements.
- Broad current knowledge of clinical development processes, roles and responsibilities
- Strong, dynamic leadership or management experience (including study or project management) with consistent delivery against commitments and goals
- Strategic and forward thinking, creative in solution development, independent decision making, prioritization, and managing multiple tasks abilities - able to make sound, timely decisions within areas of own responsibility and recognizes when and how other stakeholders need to be involved.
- Communicates effectively with credibility and confidence to present clear messages from complex information/data to all levels in the organization.
- Ability to influence a variety of stakeholders, external parties and colleagues, at a range of levels in the organization.
- Able to choose and deploy a broad range of influencing strategies. Strong customer focus.
- Leading Innovation & Change / Innovate, learn and change