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 czarina.ortiz-scolari@mantellassociates.com.