ROLES & RESPONSIBILITIES:
• Provides 3rd party lab for civil work testing data management leadership within the study team to align on and drive data collection requirements for one or more complex 3rd party lab for civil work testing development projects
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• Well versed with Asphalt, Concrete and various type of soil testing as per BSi and ASTM standards.
• Experience in handling government civil projects for 3rd party lab for civil work testing etc.
• Efficiently plans, coordinates, and delivers complete, high quality and reliable 3rd party lab for civil work testing data in a timely manner for assigned projects
• Responsible for end-to-end 3rd party lab for civil work testing data management activities and serves as a primary point of contact for internal and external study team members
• Provides strong quality and project oversight over third party vendor responsible for data management deliverables
• Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (External Data, Safety Gateway). Enforces data standard conventions and quality expectations for 3rd party lab for civil work testing data per defined processes
• Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
• Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness
• Represents DM on cross-functional project teams & submission Teams
• Lead or support the Health Authority inspections and audits
• Provides coaching and quality oversight of junior Data Management Leads
• Attending trainings of quality & safety, weekly safety dialogues
• Identifying work hazard & apply control measures, using PPE and implementing RAM’s standards
• Satisfy internal customer (production team)
• Equipment safety and cleaning, safe work environment
• As per specification follow quality control plan
• Handling chemicals based on MSDS, assisting during the training of products
• Assists the development of manufacturing activities, through all type of laboratory work, conducting well defined process studies and participating in the administration of the laboratory works as one of a small team of technicians.
• Quality control duties including the collection of samples, testing and recording resulting QC database and keeping work area and equipment clean and in good order.
• Responsible for generation/coordination of labels for IMP, list/randomization list/randomization schedules and ensures agreed milestones, quality and costs are met.
• Is accountable for label compliance with respect to study design, pack design, pack material, analytical specifications of the IMP along with country specific regulatory requirements and ISO 17250, 9001, 14001, 45001 standards of compliance.
• If nominated leads overall governance and/or maintains Phrase Library (validated repository of country specific regulatory requirement and translations of phrases in country specific languages)
• If nominated be a system owner for Labelling system and Randomization Reporting Tool (RRT) and lead/co-lead system enhancement initiatives as appropriate.
• If nominated be a qualified GMP line unit checker for label(s), as defined in SOP, drive culture of quality within the team. Leads investigations if certified in case of quality events/deviations or any non-Right First Time (RFT) cases when required.
• Keeps clear alignment with all the internal (e.g., 3rd party lab for civil work testing fTrial Supply Managers, Supply Chain Managers etc.) and external (e.g., external label service providers for specialized labels) stakeholders for IMP label related activities. Is responsible for communicating challenges to internal and external stakeholders and bring solutions to mitigate any risk(s). Leads as a subject matter expert/functional expert on label process during internal/external inspections.
• Is responsible for communicating challenges to internal and external stakeholders and bring solutions to mitigate any risks on project level. Adapts priorities in response to changing needs. Knows when to act independently or when to escalate issues. Support the Business owner by coordinating the vendor management and vendor performance.
• Manages all applicable finance activities, including grants, purchase orders (PO) and invoice approval for IMP labels, as applicable. Works closely with BPM (Business Process Manager) to define processes, identify and support initiatives for process improvement and simplification, deliver key functional objective(s) along with high quality standards and operational excellence when required.
• Be a mentor for the new CLM associates if nominated. Ensures colleagues know and use the appropriate processes and procedures and are aware of the risks of non-compliance. Supports Business Process Manager (BPM) to assess risks related to CLM and have robust process in place.
• Actively participates in projects, networks and/or forums. Acts as a role model for Novartis values and behaviors.
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+965 60637984