Role overview

Qualifications

8-10 years working in clinical data management
Experience working for small to midsize pharma/biotech companies
Outsourced CRO oversight experience
Experience as a Lead DM for Phase II and III studies in the last 3-5 years

Responsibilities

Act as the Lead DM on assigned studies, overseeing the CRO and managing the study lifecycle related to Data Management
Standardize and manage the clinical data flow process for analysis purposes
Serve as the main point of contact for the CRO and in-house team, ensuring timelines and quality
Ensure data quality in support of clinical study data milestones and deliverables

Key facts

Remote from: Anywhere
Full time
Senior (5-10 years)
Data Manager
English

Hard skills

Clinical Data Management Medidata Rave Lifecycle Management Data Quality Assessment Stakeholder Communications Organizational Structure

Other skills

Timelines

About the company

Katalyst CRO

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!

Company details

Company size51 - 200

Links

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Job description

Responsibilities:

Act as the Lead DM on assigned studies, providing oversight of the CRO and owning all aspects of the study lifecycle as it relates to Data Management
Standardizes and manages the clinical data flow process to data delivery for analysis purposes.
Be the main point of contact for the CRO and in house team, communicating and managing timelines effectively ensuring work is completed on time and at high quality
Ensure data quality in support of clinical study data milestones and deliverables.
Interacts and manages relationships with other functional areas to ensure high quality data management activities.

Requirements:

8-10 years working in clinical data management and specific experience working for small to midsize pharma/biotech companies (must have direct sponsor)
Must have experience with outsourced CRO oversight experience
Experience as a Lead DM for Phase II and Phase III studies within the last 3-5 years, with the willingness to work hands-on
Expertise with Medidata RAVE
Strong communication and organization to manage DM timelines, deliverables etc