Trial Manager

United States

Apply with AI Apply

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Clinical Trials, Healthcare TechnologyIndustries

Requirements

Candidates should possess strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process, and clinical monitoring procedures, with over four years of experience managing and coordinating clinical trials in a project management or clinical operations role. Experience with study start-up, EC/IRB applications, and utilizing different software for clinical trial delivery, particularly in decentralized or remote trials, is also required. Previous startup or biotech experience is a plus.

Responsibilities

The Trial Manager will lead and manage the day-to-day running of CTIMP and non-CTIMP clinical trial programs and projects, ensuring successful delivery on time, within budget, in compliance, and to a high quality. They will act as the primary liaison between Lindus Health and the Sponsor, coordinating activities and deliverables of all project partners and proactively identifying and managing issues. The role involves maintaining project information on various databases, evaluating project progress, providing oversight for inspection readiness, developing contingency plans, and facilitating team training. Additionally, the Trial Manager will direct the activities of assigned Project Support staff, mentor team members, and develop project plans in accordance with Lindus Health standard operating procedures.

Skills

Clinical trial management

Clinical operations

Good Clinical Practice (GCP)

ICH guidelines

Study start-up

EC/IRB applications

Clinical trial software

Decentralized trials

Remote trials

Multi-site trials

IND/CTIMP trials

Project management

Sponsor liaison

Issue management

Reporting

Communication

Inspection readiness

Startup environment

Biotechnology environment

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.

Land your dream remote job 3x faster with AI

Try Jobo Free