• Lead clinical category strategy including vendor relationship management and governance.• Lead strategic partnership RFP exercises for trial related services per business needs and oversee the subsequent vendor onboarding.• Leads study proposal requests, vendor selection and award, and study budget negotiations with CROs and other clinical vendors.• Supports portfolio and study oversight structure through vendor and risk management and serves as escalation point for study teams.

-Provide proactive management across category(s) of vendors and be primary contact for vendor advice and expertise.-Identify key vendors aligned to Category strategy and oversee initial contact/relationship building-Onboarding vendor(s) and integration to IQVIA network portfolio. -Contracting and competitive rate negotiation. -Administration of project level contracts. -Governance management, including KPI tracking and escalation management.

• Conduct site selection visits in partnership with CRA and liaise with contract analyst to negotiate site budgets• Educate site staff on study protocol and procedures• Conducts presentations and in-services on protocol and study drug • Work with sites to compile and revise recruitment plans• Establish site referral networks• Conducts visits to study sites

• Supervise a team of clinical research coordinators/assistants & assess professional development• Manage multiple clinical trials and protocols over various therapeutic areas• Create, evaluate, pilot and implement new research related training and SOPs to the organization• Serve as a Lead coordinator whose responsibilities include but are not limited to:- Participation in study feasibility - Screen, consent, and enroll subjects- Dispensation of the study medication and drug accountability- Collect, interpret, and record study data- Oversight with lab manager over collection and processing of study samples - Manage study supply inventory and orders - Submit documents and amendments to IRB and study sponsors- Administer QA/QC of team’s ongoing clinical trials - Maintain up to date regulatory binders and study documents- Conduct other required research assessments and procedures

o Supervise, train and mentor team of research personnel• Screen, consent, and enroll subjects and follow their progress through end of study• Collect, interpret, record, and enter study data, resolving queries and inconsistencies• Obtain and process study specimens, maintain inventory logs for sample repository and manage sample shipments from Duke and into Duke from external sites• Project manager for multi-site grant funded studies including overseeing large multidisciplinary team, budget, and supply logistics• Compile and submit regulatory documents and amendments to IRBs and trial/grant sponsors, including designing and editing protocols, ICFs, research plans and/ or other essential documents• Evaluate study progress through internal audits, troubleshoot problems, and make recommendations to division manager to improve quality, efficiency and output