Harvest Integrated Research Organization (HiRO) is a globally-oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial pathways. As an emerging global CRO, HiRO collaborates closely with biotech and pharmaceutical companies, aiming to efficiently bridge the gap between laboratory research and market commercialization. Our team members are curious and determined, always looking to transform challenges into opportunities. Our mission is to provide cutting-edge and capital-efficient solutions, ultimately benefiting patients worldwide.
We are seeking a Data Management Lead based in Philippines to join our dynamic team
Key Responsibilities
- Serve as Lead Data Manager for one or more clinical trials assuming responsibility for DM activities including selection and application of data acquisition standards, database design, development and maintenance of the Data Management Plan, data review and query management, data access, Data Management metrics reporting, database release, and submission related activities.
- Provides early input into protocol design, contracting process focused on data management issues;
- Proactively communicates with project team to share project status, risk assessment and outstanding item resolution status. Ensures compliance to standard key performance indicators according to process
- Leads the development of eCRFs, database and all the other DM activities for the study handled internally by interacting with other functional area representatives;
- Ensure the TMF maintenance of Data Management is on time with good quality.
Qualifications
- Bachelor's Degree Clinical, biological or mathematical sciences or related field, or nursing qualification Req
- 7 years of relevant work experience including people management. Equivalent combination of education, training and experience.
- Advanced knowledge of Data Management processes and systems.
- Solid understanding of clinical drug development process and production of Data Management deliverables
- Proven Staff management skills, strong leadership, motivational and influencing skills.
- Strong organizational skills, metrics calculations, and time management skills.
- Strong verbal/written communication skills.
- Ability to work on multiple projects and manage competing priorities effectively
- Effective mentoring and developed coaching skills.