Centralized Start-up Lead

2 weeks ago

Port Melbourne, Australia Labcorp Full time

**The Opportunity**

The Centralized Start-up Lead primarily oversees and manages the amendment phase of domestic and/or international clinical trials. Where required, may also take on start-up tasks under direction of the Start-up Lead.

**Responsibilities (but not limited to)**
- Develop an amendment submission and approval strategy in conjunction with the Project Lead, other functional groups and the client to ensure amendment deliverables are completed within agreed project timelines and in accordance with client’s expectations
- Understand client expectations for deliverables/milestones, and liaise with applicable functional teams in creation and modification of site activation timelines throughout the lifecycle of the project
- Oversee preparation of amendment submission including but not limited to ICF updates/review/approval and other necessary documents
- Oversee ethics and regulatory bodies submission and approval status. Coordinate addressing queries ensuring required timelines are met
- Contribute to a Start-Up Plan if required, overseeing Investigator Package compilation, green light approval and contributing to a cross functional team ensuring that sites achieve Ready to Enroll status on time
- Ensure that work is performed within budget.
- Present at external and internal meetings including, but not limited to: project core team and client meetings.

**Requirements**:

- Four (4) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), including demonstrated skills and competency in study start-up and/or amendment management.
- Preferably local project coordination and/or project management experience
- University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
- Competitive remuneration package on offer
- Amazing company culture with a supportive and inclusive team environment
- On-going career development on offer

**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.

For more information about how we collect and store your personal data, please see our Privacy Statement.

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