Trial Lead

Germany

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Clinical ResearchIndustries

Requirements

Candidates must be fluent in German and possess a strong understanding of Good Clinical Practice (GCP)/ICH guidelines, regulatory requirements, the drug development process, and clinical monitoring procedures. A minimum of 6 years of experience in managing and coordinating clinical trials in a project management and/or clinical operations role is required, along with experience in leading and disciplining a team. Experience with study startup, closeout, EC/IRB submissions, and various clinical trial execution software is necessary. Experience managing multi-center/multi-site and IND/CTIMP studies is essential, and experience in startup/biotech companies is considered advantageous.

Responsibilities

The Trial Lead will oversee the execution of clinical studies (CTIMP and non-CTIMP), ensuring they are completed on time, within budget, and in full compliance with regulatory standards. This role involves acting as the primary interface between Lindus Health and sponsors, managing project initiation, execution, and closeout, coordinating all project partners, and proactively addressing issues. The Trial Lead will also collaborate with technology and product teams to develop clinical trial solutions, work with the quality management team to develop validation standards, and support business development with sponsors and vendors.

Skills

Clinical Trials

Project Management

Regulatory Compliance

CTIMP

Sponsor Relations

Lindus Health

Accelerates clinical trials for life sciences

About Lindus Health

Lindus Health focuses on speeding up clinical trials to help patients access new treatments more quickly. The company operates differently from traditional contract research organizations (CROs) by using a fixed-price model for studies and milestone-based payments, which aligns their incentives with those of their clients. Lindus Health combines a skilled clinical operations team with a specialized software platform and access to a vast database of 30 million Electronic Health Records. They handle all aspects of clinical studies, including designing the study, recruiting patients, capturing clinical data, monitoring progress, and managing projects. With their approach, Lindus Health has successfully assisted over 90 sponsors in conducting clinical trials across the US, UK, and Europe, completing them up to three times faster than conventional CROs and often delivering results ahead of schedule.

London, United KingdomHeadquarters

2021Year Founded

$23MTotal Funding

SERIES_ACompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Health Insurance

Unlimited Paid Time Off

Flexible Work Hours

Mental Health Support

Enhanced Parental Leave

Professional Development Budget

Cycle to work scheme

Stock Options

Regular team events

A new laptop as your main workstation

Risks

AI-driven diagnostics could challenge Lindus Health's market position in clinical trials.

Rapid pathogen evolution in infectious disease trials requires continuous adaptation and innovation.

Demand for diverse patient populations may strain recruitment capabilities in less diverse regions.

Differentiation

Lindus Health accelerates trials using a unique software platform and 30 million EHRs.

They offer fixed-priced quotes and milestone-based payments, aligning incentives with clients.

Their 'All-in-One CRO' solutions cater to specific therapeutic areas like cardiovascular and infectious diseases.

Upsides

Decentralized trials align with Lindus Health's patient-centric approach, enhancing participant reach.

AI integration in trials complements their goal of accelerating clinical trial timelines.

Wearable technology in trials supports continuous monitoring, beneficial for cardiovascular studies.

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