Tech Observer
Website:
tech-observer.com
Job details:
Tech Observer is a Global Clinical Research Organization (CRO) & FSP Provider headquartered in Paramus, NJ, with a presence in Singapore, India, the UK, Denmark, and over 20 other countries. (www.tech-observer.com).
We are looking for Data Operation Project Manger for one of the sponsor in Mumbai ( 3 days WFO in a week).
Primary Job Function
- For clinical studies, data integration and data utilization, to manage as liaison person between the client and the CRO; or within the client organization as a process lead, the process for collecting data and data-related documents; to make the data available within the Patient Data Center (PDC) for the Clinical Teams and Brand Teams for further exploration to increase compound knowledge, for timely submission of up-to-standard data for registration dossiers for drugs within the client's organization or for prompt responding to internal and external (Regulatory Authorities) requests for information.
Core Job Responsibilities
- At study start-up, creates study settings in PDC, coordinates the review within the client organization of selected study documents, timely approves/co-approves essential clinical study documents in order to achieve study milestones within the planned timeline. Loads the study deliverables into PDC, guarantees that global client standards/requirements are met and that waivers are requested if needed.
- During study conduction and closeout, ensures the timely delivery and storage of up-to-standard datasets with supportive documentation from the CRO, as well as reviews and co-approves selected clinical study documents in order to enable access for the study team to agreed interim or final deliverables. Works as custodian for essential study data and documents that meet expected quality for subsequent Data Utilization projects and/or reproduction of the statistical output as included in the clinical study report.
- Safeguards data standardization across studies within the program/project, maintains oversight of standardization if studies of the same program/project are under different Data Operations Project Managers (DOPMs). Participates in submissions to facilitate data integration, secures uniform data management input for studies within a single program/project, and ensures the submission dossier is appropriately built up with data and related documentation.
- Reviews and provides input into critical documents for Data Integration and supports the actual Data Integration within DWS to guarantee an appropriate and complete description of available data and the production of high-quality integrated datasets/database and its proper storage in PDC.
- Ensures the delivery of high-quality Data Utilization deliverables and supporting documentation from the CRO or internal sources to properly store all related data, documentation, and statistical programs used in the Data Utilization project, as well as to facilitate rerunning the statistical programs used to produce the statistical output included in the Data Utilization report.
- May perform other duties as assigned.
Position Accountability/Scope
- Acts as a liaison between cross-functional areas and with CROs.
- Plans and prioritizes workload.
- Establishes and maintains effective relationships with team members, clients, and vendors; represents Data Operations at clinical project-related meetings and negotiates timelines.
- Approves study-related documents.
- Is accountable for high-quality, accurate clinical data made available on an ongoing, as-needed basis following the conduct of a clinical study or data utilization project. Failure to produce high-quality data could impact product registrations.
Minimum Education
- Academic degree or higher non-academic qualification in a technical or life sciences discipline.
Minimum Experience/Training Required
- At least five years of experience in Data Management or Data Processing within drug development.
- Responds appropriately to customer needs, focuses on team goals, and detects and addresses emerging problems.
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