- Project Management: Manages and oversees activities related to eClinical projects during the pre and post Live phases with primary responsibilities for managing scope, budget, quality, timelines, project deliverables.
- Project Initiation: Interface with internal and external stakeholders to understand project scope, timelines, cost, and risk. Lead internal efforts to define resources needed and request project team members
- Project Planning: Identify and manage project tasks, dependencies, and critical paths. Document these on a project plan/schedule. Actively participate in identifying, mitigating, and managing risks
- Budget Management: Partner with Business Development to keep all activities within scope and budget.
- Project Implementation and Management: Develop and drive project schedules to ensure timelines are met. Coordinate and facilitate internal and external project meetings, oversee project documents, and communicate project status
- Project Amendments: Understand system amendment scope and facilitate conversations about scope, timelines, cost, and risk with clients and internal teams. Manage the Change Control process
- Project Maintenance and Close-Out: Conduct routine project reviews, establish and implement corrective actions, and ensure timely delivery and completion of project deliverables
- Customer Service: Manage and oversee activities to ensure a successful client experience. Including, but not limited to:
- Provide customer service that meets or exceeds customer expectations in alignment with business capabilities
- Manage and oversee project execution and on-time deliverables
- Define roles and responsibilities to ensure accurate and timely exchange of information to support project and supply chain strategies
- Serve as the primary point of contact and initial escalation point for all internal/external project challenges
- Manage and grow the customer relationship
- Design and Support of eClinical Systems: Including, but not limited to:
- Design eClinical solutions for the trial in collaboration with the customer and internal Almac teams.
- Ensure eClinical system access, optimal system set-up and ongoing maintenance of the eClinical systems occurs in line with customer expectations.
- Manage, participate in and oversee all activities necessary in the support of eClinical systems
- Serve as the primary point of contact for the customer
- Associate’s degree with minimum of two years industry related experience OR Bachelor’s Degree
- 3 + years of experience working as a project manager or similar role
- 3+ year experience with clinical technologies like eCOA (ePRO, ClinRO, ObsRO)
- Able to coordinate and lead team efforts with moderate supervision
- Assists less experienced peers through training and mentoring
- Able to contribute to departmental standards/processes
- Independently and proactively remediates risk
- Able to identify and manage/resolve dependency and risk. Show good judgment when to bring other SMEs into the situation in a timely manner.
- Works on moderate and complex studies/program; may include high risk/critical projects
- Able to identify, manage, and resolve dependency(ies) and risk
- Shows good judgment and knows when to partner with additional SMEs
- Influences peers and team members
- Excellent Project Management skills consistently applied to wide range of projects or tasks
- Good working knowledge of other departments’ processes and able to use that knowledge as applicable
- Shares knowledge with individuals/team
- Drives and leads change with moderate to minimal supervision through departmental initiatives
- Able to participate in cross-functional initiatives
- Owns and actively performs primary SME responsibility for moderate client/product group, with some guidance
- Independently owns secondary SME responsibility
- Bachelor’s Degree in life sciences or a related field
- 1+ years of experience with clinical technologies like eCOA, ePRO, and RTSM
- Knowledge of IT principles, concepts and methods in relation to project subject matter
- Ability to manage teams to meet aggressive project timelines, while sustaining high performance, and high quality is essential
- Knowledge of the clinical trial process and related industries
- Knowledge of randomization schemas and drug management
- Familiarity with industry regulatory requirements (GxP)
- Thorough working knowledge of web, mobile-based, and IVRS systems
- Knowledge of project management
- Ability to handle multiple tasks effectively, with minimal management supervision
- Ability to effectively prioritize work, anticipate and proactively identify problems/risks, and develop and apply innovative solutions
- Strong analytical thinking and problem-solving skills
- Strong communication skills (written and verbal)
- Strong interpersonal skills
- Strong customer service skills
- Medical, Vision & Dental benefits from the 1st of the month following start date
- 20 days PTO per year, accrued monthly following start date
- 12 holidays per year as well as one day for Annual Diversity Day
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- Hybrid work available for applicable roles
- Professional development programs/ continuous learning opportunities