Clinical Operation Manager - Regulatory and Start-up

You will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. The role may also include maintenance activities. This is not a line management position but requires good project leadership skills.

Responsibilities include, but are not limited to:

• Support to country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).

• Oversees and tracks clinical research-related payments. Payment reconciliation at study close- out. Support of Financial forecasting in conjunction with other roles.

• Contribute to Execution and oversight clinical trial country submissions and approvals for assigned protocols.

• Develops local language materials including local language Informed Consents and translations.

• Interact with IRB/IEC and Regulatory Authority for assigned protocols.

• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.

• Contributes to the development of local SOPs.

• Provide support and oversight to local vendors as applicable.

• Coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.

• Support of local regulatory and financial compliance. Ability to communicate well with investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
• Works in partnership internally with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations,

• Contribute or lead initiatives and projects adding value to the business, as appropriate/required.

• Contributes to team knowledge by sharing best practices as appropriate/required.

Requirements:

• 3-5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.

• Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.

• Knowledge of budget and contract negotiations, local submission and approval processes, and understanding of how these impact study start-up.

• Requires strong understanding of local regulatory environment.

• Advanced level of English and local language.

• Good negotiating and communication skills with ability to challenge, if applicable.

• Effective communication, organizational, and interpersonal skills.

• Ability to work independently and to effectively prioritize tasks.

• Ability to manage multiple projects.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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