Clinical Operations Manager
il y a 1 semaine
IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward
With access to world-class training and professional development, we'll give you the tools you need to create the career you want.
ESSENTIAL FUNCTIONS OF A COM
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.
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 researchrelated payments. Payment reconciliation at study close
- 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:
- 35 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
- Requires strong understanding of local regulatory environment
- Advanced level of English and local languages
- 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 strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential._
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