Project Manager Start Up - com - Home Based Italy

Labcorp; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading company in the clinical trial sector is seeking a Clinical Operations Manager in Italy. The role involves overseeing local trial activities, ensuring regulatory compliance, and managing budgets effectively. The ideal candidate will have strong negotiation skills and experience in clinical operations, focusing on delivering quality and meeting commitments.

Competenze

• Proven knowledge in budget and contract negotiations.
• Ability to influence external partners and stakeholders effectively.
• Expertise in local regulatory environments and submission processes.

Mansioni

• Execute local operational clinical trial activities with oversight.
• Manage country and site budgets, ensuring compliance and timely payments.
• Develop local language materials for trial submissions and approvals.

Conoscenze

Budget negotiations

Contract management

Risk management

Regulatory compliance

Oversight of clinical processes

Descrizione del lavoro

The COM is accountable for the execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance at a country operations level.

The position significantly influences how a country can deliver specific trial commitments and objectives, especially during study start-up. The ability to indirectly influence investigators, vendors, external partners, and country managers to meet these commitments is essential. This includes adhering to budget targets and payment timelines, resolving issues, and maintaining expertise in country-specific regulations, laws, and procedures with minimal support from client management. The role requires skilled knowledge of budget and contract negotiations, local ethics, legislation, regulatory environment, submission and approval processes, development of local Informed Consent documents, and other site-related deliverables.

The position also involves proactively developing risk management and mitigation plans in the country and resolving issues locally.

Financial Responsibilities

• Ownership of country and site budgets.
• Delivering clinical and financial contracts within fair market value through continual interaction with the local clinical team.
• Oversight and tracking of clinical research-related payments.
• Payment reconciliation at study close-out.

Country Submissions & Local Language Materials

• Execution and oversight of clinical trial country submissions and approvals for assigned protocols.
• Development of local language materials, including Informed Consents and translations.
• Partnering with IRB/IEC and Regulatory Authorities for submission and approval processes.

Management & Quality Oversight

• Managing country deliverables, timelines, and results for assigned protocols.
• Contributing to the development of local SOPs.

Collaboration

• Working closely with internal teams such as Clinical Operations, Quality, Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal, and regional operations, as well as externally with vendors, sites, IRBs/IECs, and Regulatory Authorities.

The authority to ensure country deliverables are obtained for submissions, budgets, CTRAs, and milestones is held by this role.

It involves collaboration with regional operations to align timelines and oversight of local vendors as applicable.

Local Process Oversight

• Managing supplies, import/export requirements, destruction, filing, archiving, retention, and insurance processes.
• Updating country information in clinical, regulatory, safety, and finance systems.

Labcorp is proud to be an Equal Opportunity Employer. We value diversity and inclusion and do not tolerate discrimination or harassment. Employment decisions are based on business needs and individual qualifications without regard to legally protected characteristics. We encourage all qualified individuals to apply.

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