The Project Manager is accountable within their region for the successful execution of study deliverables and  the quality execution of protocol procedures through adherence to good clinical practices (GCP), evolving regulatory requirements, and ensuring quality and  consistency in timely completion of monitoring activities. Accountable for coordinating rapid start up activities across assigned countries in collaboration with the CRO. The PM will also drive adherence to timelines and milestones of study goals as well as identifying, managing and communicating risks to the study team and preparing mitigation plans. 

Principal Responsibilities

• Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies).

• Proactive reporting of study-specific issues (including monitoring metrics) to the study team via the Study Lead Country Operations (SLCO). 

• Quality of monitoring oversight in the country for assigned study(ies). 

• CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party).

• Negotiation of site study contracts and budgets for the assigned studies at country level.

• Review of local regulatory documentation and oversight of local regulatory activities. 

• Relationship management with the national coordinating investigator as applicable and coordination of country level engagement activities.

• Scheduling and leading effective country calls with local study team and/or CRO, as applicable.

• Working with Medical Affairs to coordinate site feasibility. 

• Oversight of EC/CA submissions and facilitate resolution of queries. 

• Reviewing and approving site selection visit reports

• Supporting CRAs onboarding, coordination of study specific training of CRAs for assigned trials, and oversight of CRAs on assigned studies

• Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies and communicate monitoring deficiencies to SML as applicable.

• Inspection readiness activities coordination at local level for assigned studies.

• Providing feedback to Internal and External Stakeholders as appropriate according to the relevant plans (i.e: communication plans).

• Developing and maintaining project management tracking tools (e.g: CTMS, smart sheets, etc).

Qualifications

• Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required.  A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred.

• 5+ years of relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred.

• Experience in all study phases and in rare medical conditions preferred.

• Proven experience in the oversight and delivery of operational aspects of all stages of of clinical trial process.

• Ability to lead, troubleshoot and influence for quality and delivery.

• A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected.

• Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods). 

• Good organizational skills and ability to deal with competing priorities

• Effective communication skills (written, verbal and presentation)

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com