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?

In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.

We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com

General description:

-Responsible for activities related to study start up and ongoing study document management

-Act as point of contact for local study teams and external stakeholders

Minimum qualification:

-≥ 3 years of industry related experience, including handling of trial start-up activities coordination of trial start-up activities and Health Authority / Ethic Committee submissions

-Thorough understanding of GCP, ICH Guidelines and Country regulatory environment

-In depth knowledge and understanding of clinical research processes, regulations and methodology

- Demonstrated organizational and planning skills and independent decision-making ability

-Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives

-Strong organization and time management skills and ability to effectively manage multiple competing priorities

- Ability of critical thinking and risk analysis

-Strong English (oral & written) and local language capabilities in (Ex-US)

Duties:

-Independently manages multiple country, study and site level deliverables during start-up and maintenance both within BMS and external business partners and vendors, when required.

-Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones

-Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents

- Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.

- Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).

- Collaborates with other internal roles in country feasibility and site selection.

- Collaborates directly with the BMS internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines

- Prepare country Informed Consent Form (ICF) and manage country ICF template

- Review and approval of Site ICFs

-Review and approval of Clinical Trial Package (CTP) documentation

- Update national registries as applicable

- Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management

- When applicable, conduct drug/IMP label review & translation

- Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal

- May support the collection and distribution of documents from / to sites including obtaining insurance certificates

- May support Health Authority inspection and pre-inspection activities

- May support audit preparation & Corrective Action / Preventative Action preparation for local related issues

Location: Rome, 2/3 days at the Sponsor's office

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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