Offer summary

Qualifications:

8-10 years of experience in clinical data management, preferably in small to midsize pharma/biotech companies., Direct experience overseeing outsourced CROs is required., Experience as a Lead Data Manager for Phase II and III studies within the last 3-5 years., Proficiency in Medidata RAVE and strong organizational skills are essential..

Key responsabilities:

Lead Data Manager on assigned studies, overseeing CRO and managing the study lifecycle.

Standardize and manage the clinical data flow process for timely data delivery.

Serve as the main point of contact for the CRO and in-house team, ensuring effective communication and timeline management.

Ensure data quality to meet clinical study milestones and interact with other functional areas for high-quality data management.

Katalyst Healthcare's & Life Sciences (Katalyst HLS) is a Global Contract Research Organisation that provides End-to-End Clinical Research Services for Healthcare and Life Sciences companies globally. At Katalyst HLS offers ICH-GCP compliant clinical trial services from Phase I–IV in all key therapeutic areas to support clinical development and research requirements and also provides validation, quality and regulatory services for Pharma/Bio-Pharma/Medical Device industries. Services:- Clinical Trial Management- Clinical Data Management- Biostatistics & Statistical Programming- Medical Writing- Pharmacovigilance- Quality and Regulatory Affairs- GMP, GLP and GCP Validations- Manufacturing Process Validations- Equipments & Instruments Validations- Computer Systems Validations- Human Resourcing

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