Clinical Operations Manager- Study Start Up
- BS plus 7 years OR MS plus 5 years of relevant experience in the Pharmaceutical, Biotech or Healthcare Industry with an emphasis on drug development and project management, ideally in a multidisciplinary environment
- Superior interpersonal skills and expert team player with demonstrated ability to build collaborative relationships at all levels inside and outside of the organization, specifically with line management staff and with management at all levels in partner vendor organizations
- Superior negotiation skills
- Demonstrated experience managing multiple strategic partnerships
- Solid knowledge of drug development process; preferably of vaccines development
- Superior analytical skills and ability to think / frame problems strategically
Well-organized, excellent time management with respect to priorities and self-management
- Able to work in ambiguous circumstances and take actions quickly while involving the right team members in the right situation at the right time
Strong line management skills
The position has accountability for appropriate availability and utilization of external partner support of all Phase I-IV US vaccine clinical trials to assure delivery of assigned studies to time, budget and quality expectations. This includes high level management of US clinical site deployment across the US Vaccines portfolio of clinical studies and ensuring that other third parties providing a variety of deliverables in support of clinical studies are coordinated across the US Clinical Operations team in alignment with global Vaccines vendor strategies and practices. The position has line management accountability for internal and vendor staff involved in clinical site start-up activities.
EXTERNAL VENDOR MANAGEMENT
- You would serve as primary US Vaccines Clinical Operations point-of-contact with business partners and leaders within and beyond US organization to manage flexible resourcing deployment, agree optimal study execution approach and quantify external resource requirements across time and as portfolio needs evolve
- You would consolidate results of internal oversight assessments of vendor performance and share feedback with internal vendor alliance management groups as appropriate
- To the extent necessary, you would ensure all locally-specific requirements are communicated to vendor(s) and that vendor plan to assure vendor staff competency is adequate
CLINICAL INVESTIGATOR RESOURCE POOL MANAGEMENT
- You would be responsible for clinical investigator deployment across the portfolio to ensure clinical site availability is not rate-limiting to clinical development plans within country
- You would lead the management of historical performance information of GSK investigators and identification of potential investigators without GSK Vaccine history to ensure that potential US investigator pool is understood and can be strategically managed across portfolio
- You would build and develop new investigators to address new therapeutic areas and increase number of potential investigators in high-demand areas
- You would provide projected subject recruitment timings and other input in support of development planning and country feasibility assessments at both study and portfolio level
- You would ensure delivery of list of sites to be considered for each study based on strategic site allocation considerations across the portfolio
CLINICAL SITE CONTRACTING MANAGEMENT
- You would be accountable for managing the staff and activities associated with negotiation and execution of contracts with external investigators participating in clinical trials
CLINICAL SITE COLD STORAGE UNIT, ANCILLARY SUPPLIES, AND SAMPLE MANAGEMENT
- You would be accountable party within GSK for oversight/ownership of external (non-GSK) vendor managing clinical site cold storage unit (refrigerators & freezers) validation process (includes initial assessments and periodic re-validation)
- You would manage and or foster new vendor relationships and improve the process to deliver clinical ancillary supplies and the coordination of sample management within the region.
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