Clinical Trials Expert

Poste

Temps plein

Permanent

Senior

Santé

Modalités

Basel

Clôture dans 30 jours

Exigences

Bachelor

Permis UE/AELE

Compétences

Digital biomarkerseCOAIxRSStudy startup coordinationCentralized endpoint reviewKPI implementationCollaborationStakeholder engagementTraining and DevelopmentProjektmanagementProduct developmentClinical trials

Description

The Opportunity As part of the CO Community, the Clinical Trial Expert is accountable for a range of end to end study-level activities from systems set up to close out during the execution of trial(s).S/he is responsible for the delivery of operational systems and technical activities (e.g. eCOA, IxRS) in support of the Study and Programme delivery within timelines, budget, quality, while contributing towards the CO North Star of improving productivity and approaching study delivery from a patient centric mindset. The Postholder is accountable for delivering strategic components within their area of expertise that improve CO's productivity metrics. The role also requires enterprise-wide interconnectivity, networking, and monitoring of the internal and external environments.

Responsabilités

Ensure the Clinical Operations organisation achieves and maintains a sustainable high level of portfolio delivery performance by implementing and maintaining study-specific solutions that deliver on the CO goals and objectives in your domain of expertise (e.g. IxRS, eCOA).
Lead the implementation of systems maintenance, tools and reports required across the clinical trial life cycle (eCOA, IxRS, etc).
Coordinate components of study startup, including input into / ownership of requests for proposal, authoring of documents and potentially site personnel training.
With a strong background in trial system implementation and execution, you contribute to specific study strategies pertaining to your domain of expertise.
Establish and maintain optimal relationships with key internal and external partners and stakeholder groups.
Contribute to the development and maintenance of relevant study oversight documentations/charters, processes and best practices as needed and represent pRED at cross-enterprise CO forums.
In your relevant domain of expertise, track study progress and address issues that may come up in close collaboration with study teams, affiliates, sites, and CROs as appropriate.
Collaborate with stakeholders in generating relevant reports and KPIs to monitor trial progress.
Identify signals and systematic areas for improvement at an Enterprise level.
Establish standard approaches and provide support across the clinical portfolio in a range of activities such as Training Materials, Processes, SOPs, etc.

Exigences

You hold a university degree (or equivalent experience, preferably in life sciences) and possess deep experience in the pharmaceutical/healthcare industry and drug development (therapeutic area a plus), alongside a solid understanding of the clinical trial environment, ICH-GCP, and lifecycle sequence/interdependencies.
You are highly experienced in clinical trial management tools, systems, and their interdependencies, specifically including IxRS, eCOA, centralised endpoint review (such as images, ECG, etc.), and digital biomarkers.
You possess a solid grounding in business performance improvement methodologies—including project conceptualisation, situational analysis, solution design, implementation, and continuous improvement—and have the ability to collaborate with a range of stakeholders to implement the strategic direction for early development clinical studies.
You find passion in achieving successful outcomes by leading, coaching, and inspiring others, while thriving in fast-paced, ambiguous, and highly collaborative environments where you can think on your feet, show a growth mindset, and embrace learning through experience.
You bring strong problem-solving, analytical, negotiation, and interpersonal skills (both written and oral), and you feel completely comfortable travelling internationally based on specific program needs.

Technologies

IxRSeCOA

Avantages

At Roche, we aim high to deliver life-changing healthcare solutions.
If you’re ready to make a meaningful impact on patients and healthcare systems worldwide, this is the place for you.

Entreprise

Roche

Pharmaceuticals

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.