ZEINCRO, a leading Contract Research Organization which provides full range, high quality services to the pharmaceutical industry is looking to recruit:
a Senior Data Manager (DMO/SrDM) and a Lead Data Manager (DMO/LeadDM) to join an international team of professionals working on global projects
Purpose of the role:
The SrDM and Lead DM are responsible for all operational aspects of clinical trial data management oversight including the delivery of every milestone on time within budget and scope in compliance with GCPs, SOPs and standards.
They are responsible for the coordination of internal/external resources and third parties/vendors for the flawless execution of the study.
They are involved in the scientific conduct of the study and act with a critical thinking and problem-solving mindset.
They are also responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning.
Required Skills & Knowledge:
- Bachelor’s degree or Bachelor’s with Advanced Degree in scientific discipline.
- At least 5 – 7 years of experience in the pharmaceutical industry or clinical-related discipline (including at least 2 years of clinical research experience) for the SrDM role or more than 8 years’ experience for the LeadDM role.
- Prior experience in project management and/or supervisory experience in coordinating international Phase I – III clinical trials is strongly required.
- Ability to lead the study team and efficiently work with other DMs in the same study.
- Ability to manage and lead international meetings (e.g. Study Teams).
- Ability to anticipate, timely escalate issues and define appropriate action plans.
- Ability to lead transversal projects.
- Capability to challenge decisions/status-quo/requests using risk management approach (e.g. unrealistic timelines, unplanned database snapshot).
- Ability to work cross-functionally fostering team spirit and team motivation (e.g. study team or transversal project team).
- Demonstrate stakeholder management skills (e.g. ability to manage expectations).
- Good organizational skills including attention to detail and multi-tasking skills.
- Ability to develop and maintain an optimized study planning with other functions (including identification of critical path).
- Ability to coordinate multiple interfaces, both internally and externally.
- Ability to work autonomously to efficiently and effectively provide status reports.
- Capability to routinely perform oversight on data management activities (data review and analysis, both clinical& operational, to propose actions and a remediation plan).
- Ability to appropriately delegate responsibilities for outsourced activities and experience in vendor management for outsourced activities.
- Strong English skills (i.e., ability to exchange fluently including negotiation, lead international meetings, write meeting minutes/ emails/ study documents / internal & external communication).
- Make decisions when needed and take responsibility (accept accountability for results, even if the outcomes are difficult or sensitive).
- Ability to effectively interact with scientists and managers within and outside Clinical Sciences Organization (CSO), serving as an internal consultant on the assigned area (e.g. Subject Matter Expert) and liaise with external organizations on projects.
- Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers).
- Demonstrated ability to adapt and be flexible to change, managing internal and external challenges & opportunities.
- Knowledge of industry data management standards and practices.
- Understanding of database concepts.
- Experience with MediData Rave is a must as well as clear comprehension of SAS programming.
- Knowledge of international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems, processes, and SOPs).
- Strong working knowledge of Microsoft Office.
Join us for a challenging career!
Zeincro offers a competitive remuneration package, as well as continuous development and career opportunities in an exciting, international and supporting working environment. At Zeincro your career will flourish, as we care in supporting and developing our people.
If you are interested in this job opportunity please send your CV to: firstname.lastname@example.org