Project Manager, Research Data Operations

1.RDO Project and Resource Management
•Oversees planning, execution, and delivery of complex RDO projects-including clinical trialand research support systems-ensuring alignment with organizational priorities, regulatoryrequirements, and budget/time constraints.
•Leads and coordinates multi‑disciplinary teams, manages project scope, schedules, resources,and stakeholder communications, while producing validated, audit‑ready systems andhigh‑quality deliverables.
•Ensures adherence to PHRI SOPs, privacy and regulatory standards, maintains projectdocumentation, provides leadership and coaching, and identifies opportunities to improveRDO processes and project delivery practices.
 

2.Business Consultancy
•Provides expert guidance on technical design, system architecture, validation, usability, andregulatory standards to ensure technology solutions effectively support clinical research needs.
•Analyzes complex business requirements and research requests, proposes and documentssystem solutions, prioritizes incoming issues, and prepares proposals and time estimates for allproject phases.
•Works closely with Program Managers and Business Technology Specialists to shape technicalstrategies, recommend improvements to senior management, and support development, testing,and implementation processes.
 

3.RDO Team Supervision
•Provides day‑to‑day supervision, mentoring, and contributes to performance evaluations forRDO staff, ensuring work quality, timely deliverables, and alignment with departmental andorganizational objectives.  

- Establishes and maintains standardized project management, business analysis, and data
management processes, including templates and tools, while monitoring team workflows and
resolving operational issues.
• Leads team and project meetings, fosters cross‑departmental and external stakeholder
collaboration, contributes to project deliverables, and escalates unresolved issues when
necessary while remaining accountable for team outcomes.
 

4. Fostering/Building Collaborations
• Cultivates strong partnerships with researchers, agencies, and organizational leaders by
advising on PHRI capabilities, assessing project feasibility, and representing PHRI in
collaborative initiatives.
• Provides early‑stage guidance through demonstrations, planning input, and resource
estimation, and contributes to major funded initiatives with scope development, proposals,
financial projections, and alignment with PHRI standards.
• Works with Research, Contracts, and Finance teams to ensure budget and deliverable
alignment, interprets external policies, and represents PHRI in meetings and events to build
trust and support successful partnership outcomes.
 

5. Organizational Development / Process Improvement
• Provides senior expertise to develop, revise, and evaluate institutional policies, SOPs, and
operational processes-ensuring they align with organizational goals, emerging technologies,
and evolving research needs.
• Leads or participates in cross‑functional working groups to design, assess, and implement new
workflows or technologies, evaluating feasibility, effectiveness, and appropriateness for PHRI.
• Trains and mentors staff on new systems, methodologies, and technologies, promoting
efficiency, knowledge sharing, and a culture of continuous improvement across the
organization.
 

6. Vendor Management
• Leads vendor selection, onboarding, contract and SLA enforcement, and ensures all vendor
systems meet PHRI’s technical, regulatory, security, and audit‑readiness requirements.
• Coordinates technical setup, testing, and validation of vendor systems, maintains
documentation, tracks performance against metrics, and acts as the primary liaison to resolve
issues between vendors and internal teams.
 

7. Other duties assigned

1.Undergraduate Degree in Business, Technology or Clinical Research
2.Over 10 years in ICT and 5+ years in business analysis or project management, withformal project management training.
3.Strong experience delivering technology solutions for research and clinical trials, withknowledge of study design, regulations, and scientific methodology.
4.Proven ability to lead software development teams, manage cross‑functional groups, andmentor staff.
5.Experience liaising with industry, government, and senior stakeholders, demonstratingstrong communication, negotiation, and conflict‑resolution skills.
6.Expertise across CDMS architecture, configuration, validation, deployment, auditreadiness, UAT, documentation, and integration with clinical systems (EDC, CTMS, labs,ePRO, randomization).
7.Deep understanding of data privacy/security (PHIPA, HIPAA, GDPR), regulatoryframeworks (ICH‑GCP, 21 CFR Part 11), and data standards (CDISC, HL7).
8.Demonstrated creativity, critical thinking, and ability to translate protocol requirementsinto system specifications (CRFs, edit checks, data flows).
9.Skilled in managing vendor relationships, contracts, performance monitoring, and applyingbroad project management and system development methodologies (ALM, ITILpreferred).
10.Strong conceptual understanding of programming, integration, reporting, webtechnologies, testing approaches, and a commitment to ongoing professional development.