Senior Start-up Specialist

3 semanas atrás

Lisboa, Portugal Labcorp Tempo inteiro

Labcorp Drug Development

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

**Did you know?**

The Start Up Specialist / COM is accountable for 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 at the client.

The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. Ability to indirectly influence investigators, vendors, external partners and country managers to deliver these commitments is a

must. This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country based regulations, laws and procedures with mínimal support from the client management. The position requires skilled knowledge of budget

and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.

The position requires the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

FINANCIAL (as applicable):

- Assistance with the ownership of country and site budgets.
- Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- Oversight and tracking of clinical research-related payments
- Payment reconciliation at study close-out.

COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable):

- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
- Development of local language materials including local language Informed Consents and translations.
- Works in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols.

MANAGEMENT & QUALITY OVERSIGHT:

- Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments.
- Contributes to the development of local SOPs.

COLLABORATION:

- Works in close collaboration internally with Clinical country operations, Country Quality Manager, Finance, client Medical Affairs, Regulatory Affairs, PharmacoVigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory

Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Collaborates closely with client Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.

LOCAL PROCESS OVERSIGHT: (as applicable):

- Responsible for 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, regulatory, safety and finance systems.

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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