Associate Clinical Operations Manager (Regulatory) in München bei MSD

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for Supporting budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals.

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. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Support of Financial forecasting in conjunction with Sr.COM /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.

• Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.

• 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 in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.

• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related- interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.

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

• Contributes strongly to COM team and other Country Operations roles knowledge by acting as/supporting process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.

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

• May act as buddy / mentor.

Skills:

• Good IT skills (MS office, Clinical IT applications) and ability to adapt to new IT applications on various devices.

• Knowledge of core clinical systems, tools and metrics

• Excellent verbal and written skills, in local language and English

• Strong coordination and organizational skills

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

• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or manager.

• Ability to make decisions independently with oversight from Sr.COM or Manager.

• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. ICH/GCP knowledge appropriate to role. Good knowledge of Good Documentation Practices

• Able to work with other experienced clinical research professionals and manage select protocols independently. Works with high quality and compliance mindset.

• Problem solving is essential to this position. Requires the ability to pro-actively identify issues a