Offres d'emploi

Le poste

Clinical Project Manager

 

Presentation of the company:

AUROBAC THERAPEUTICS is a biopharmaceutical company founded in 2022 by three highly renowned life sciences innovation companies, Boehringer Ingelheim, Evotec and bioMérieux, which is advancing a robust pipeline to address high unmet medical needs associated with infections in acute hospital settings, amidst the growing antimicrobial resistance (AMR) epidemic.

With strong growth ahead, within an international environment, the company is now looking for a Clinical Project Manager.

Description:

As a Clinical Project Manager at AUROBAC THERAPEUTICS, you will be responsible for the operational planning and execution of assigned clinical studies from start-up through close-out. The CPM ensures that clinical studies are conducted in compliance with the study protocol, regulatory requirements, Good Clinical Practice (GCP), and company procedures.

You will report to the Director, Clinical Operations.

Missions:

CLINICAL STUDY OPERATIONS MANAGEMENT

✓ Manage the day-to-day operational planning and execution of assigned clinical study tasks that may span from study start-up to close-out.

✓ Help ensure studies are conducted in accordance with the protocol, applicable regulations, ICH-GCP guidelines, and company SOPs.

✓ Track study progress against timelines, milestones, and deliverables.

✓ Identify operational risks and propose mitigation strategies.

✓ Escalate key issues and risks to the Director Clinical Operations

STUDY START-UP AND SITE MANAGEMENT

✓ Support study start-up activities including feasibility, site selection, regulatory submissions, and site initiation.

✓ Support contract negotiation and site activation processes in collaboration with relevant internal functions.

✓ Monitor site performance, patient recruitment, and retention

VENDOR AND CRO MANAGEMENT

✓ Participate in the selection and operational management of CROs and study vendors

✓ Serve as the operational point of contact for vendors and service providers.

✓ Oversee vendor performance and ensure timely delivery of study services.

✓ Review vendor deliverables and ensure compliance with contractual agreements.

MONITORING OVERSIGHT

✓ Oversee monitoring activities conducted by CROs

✓ Review monitoring visit reports and ensure appropriate follow-up of action items.

✓ Ensure adequate management of protocol deviations, quality issues, and site-related risks.

✓ Perform co-monitoring visits at the investigational sites, as needed

STUDY DOCUMENTATION

✓ Contribute to the preparation and review of key study documents (study plans/manuals, CRFs completion guidelines, etc..)

✓ Ensure accurate and timely maintenance of study documentation in the Trial Master File (TMF).

✓ Ensure documentation is inspection-ready at all times.

DATA MANAGEMENT AND STUDY DELIVERABLES

✓ Collaborate with data management teams to ensure accurate and timely data collection and reporting.

✓ Participate in data review activities and query resolution processes.

✓ Support database lock preparation and study close-out activities.

BUDGET

✓ Support the tracking and monitoring of study budgets and operational costs.

✓ Review and validate vendor invoices related to assigned study activities.

QUALITY AND COMPLIANCE

✓ Ensure study complies with regulatory requirements, GCP guidelines, and company quality standards.

✓ Support preparation for audits and regulatory inspections.

✓ Contribute to the implementation of corrective and preventive actions (CAPA) when necessary.

CROSS-FUNCTIONAL COLLABORATION

✓ Work closely with internal teams including Regulatory, Quality, Data Science, CMC etc..

✓ Participate in study team meetings and provide operational input.

STUDY REPORTING

✓ Communicate study progress, risks, and key milestones to the Director Clinical Operations.

✓ Ensure accurate and timely reporting of study activities.

Personal and Technical skills:

• Fluency in English and French is a must-have

• Used to working in an international environment.

• Proven expertise in international clinical study management

• Strong knowledge of GCP (including certificate), ICH guidelines, and regulatory requirements

• Excellent communication skills and demonstrate strong ability to coordinate various stakeholders (internal and externals) involved in a clinical study

• Excellent planning and organization skills

• Proven ability to work collaboratively in a fast-paced, cross-functional environment

Education and Professional experience:

• Advanced degree in biotechnology, pharmaceutical sciences, or a related field

• At least 5 years of experience in clinical trial management within the biotech, pharmaceutical, or CRO industry.

• Strong background in managing international interventional studies across Phase I–III and in overseeing CROs, core labs, and external vendors.

 

To apply, please send your CV and cover letter application to jobs@aurobac-tx.com mentioning the reference ATX26-01.

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L'entreprise

AUROBAC THERAPEUTICS

 

AUROBAC THERAPEUTICS is a biopharmaceutical company created in 2022 by 3 renowned life sciences innovation companies, Boehringer Ingelheim, Evotec and bioMérieux, to become a global leader in the fight against bacterial infections, Antimicrobial Resistance (AMR) and their consequences in acute hospital settings.
We focus our efforts to develop the next generation of antimicrobial and acute care products, following a targeted precision medicine approach, i.e. associated with rapid diagnostics to support product use.