Start-up Assocciate - Montréal, Canada - Labcorp

Labcorp

Verified Company

Montréal, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Start-up Associate - FSP 50% Hybrid, Home/Office-based - Montreal, Quebec.

Must be bilingual in English and French. Bachelor's degree required
preferably within life sciences or equivalent.**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?

Why settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn't want twice the perks - working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.

Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research.

Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.

We are seeking a Start-up Associate to be responsible for activities related to study start up and ongoing study document management and act as point of contact for local study teams and external stakeholders.

In this role you will independently manage multiple country, study and site level deliverables during start-up and maintenance both within internal and external business partners and vendors, when required; and plan and develop strategy for start-up activities to ensure successful recruitment and delivery to trial milestones.

Additional responsibilities include:

Preparing Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
Supporting 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.
Preparing and performing submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
Collaborating with other internal roles in country feasibility and site selection.
Collaborating directly with the internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines.
Preparing country Informed Consent Form (ICF) and manage country ICF template.
Reviewing and approving of Site ICFs
Reviewing and approving of Clinical Trial Package (CTP) documentation
Updating national registries as applicable
Ensuring 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, conducting drug/IMP label review & translation.
Serving 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 preinspection activities.
May support audit preparation & Corrective Action / Preventative Action preparation for local related issues.
50% work from home and officebased.

Requirements:

Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator startup documents; previous interaction with operational project teams and investigative sites
Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe.
Good organizational and time management skills
Excellent communication / writing skills
Strong computer skills with an ability to access and leverage technology alternatives.
Abilities to review/analyze relevant data so as to assist in building evidencebased clinical trial strategies.
Selfmotivation with the ability to work under pressure to meet deadlines.
Works well independently as well as in a team environment
Detail and process oriented
Positive attitude and approach
Multitasking capability
Ability to work independently.

Great Benefits at Labcorp:

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits inc