Clinical Operations Manager
hace 2 semanas
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.
This is a homebased position and you can be located anywhere in Spain, or work from our office in Madrid.
**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.
- Hybrid working
- able to commute to office in Southern part of Athens 2-3 days a week
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