Senior Clinical Data Manager - Biotech

Posted 01 March 2023
Salary Competitive
Job type Full Time
Discipline Life Science Consulting
Contact NameCzarina Ortiz-Scolari

Job description

Mantell Associates is currently partnered with one of the most innovative and fastest growing Biotech's based in Florida. This amazing company is primarily focused on oncology and immunotherapy. They are currently in search of a Global Clinical Study Manager.

Are you experienced in Data Management?

Do you have experience managing and handling vendors, as well as a thorough background in EDF & ECRF systems?

Have you supported and planned ongoing clinical trials including overall management/oversight of all data management activities?

Are you looking for a place you can have long term growth?

This company has received $30 million Series A funding this past year to focus on research and development. They are going from strength and strength and putting them way ahead of their competitors! They are looking for a Global Clinical Study Manager that can manage vendors and navigate clinical operations.

Senior Clinical Data Manager - Responsibilities:

  • Accountable for the data management (DM) deliverables across multiple studies and is responsible for all vendor(s) oversight for outsourced DM activities

  • Act as main point of contact for client and vendor communication for DM Activities

  • Knowledgeable and experience with web-based Electronic Data Capture (EDC) systems, preferably Medidata RAVE, advanced understanding of the elements of database creation

  •  Review and contribute to the preparation of protocols, CRF's and prepare or review/contribute to data management plans, data management reports and CRF completion guidelines

  • Ensures completeness, accuracy and consistency of clinical data and data structure across all projects/studies

  • Support data management activities such as clinical data review, third party data reconciliation e.g., IVRS, SAE reconciliation, biomarker, etc

  • Knowledge of effective clinical data management practices

  • Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries

  • Assist in database upgrades/migrations including performing User Acceptance Testing

  • Participates in study level budget review activities for individual studies

  • Uses metrics and key performance indicators (KPIs) to monitor vendor performance

  • Develops a strong partnership with CRO Lead Data Managers to ensure program level deliverables are on track

  • Participate in vendor selection for data management, interactive response technology (IxRS), and other services wherein data storage may be applicable

  • Travel as needed to execute assigned responsibilities and tasks

Senior Clinical Data Manager - Requirements:

  • 8+ years in clinical data management pharma/CRO industry experience

  • University/college degree (life science, pharmacy or related subject) preferred

  • Proficient in Microsoft Office

  • Professional, proactive demeanor

  • Excellent written and verbal communication skills

  • Able to collaborate effectively with internal and external study management teams to meet project timelines

  • Familiar with CDASH/CDISC standards

  • Knowledge of MedDRA and WHO Drug coding

  • In-depth knowledge of the drug development and data management processes

  • Knowledge of time and cost estimate development and pricing strategies

  • Has a good understanding of regulatory guidelines and issues (i.e., ICH GCP), and understands the connection to DM deliverables

  • Ability to sit and stand for extended periods of time

  • Ability to carry, handle and reach for objects

  • Team player

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Czarina Ortiz-Scolari at