Almac Group is currently seeking a Project Manager, eClinical for our Lansdale, PA location. The Project Manager eClinical is responsible for the successful execution of eClinical projects; this includes communicating and driving timelines both internally and externally, working with, or on behalf of customers to ensure quality design, implementation, and maintenance of the eClinical software and services in a clinical trial. This role manages the internal teams as well as the customer relationship throughout the project lifecycle. The exact tasks performed for any given project are based upon the services quoted.
Responsibilities include but are not limited to:
- 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
Qualifications:
Required Experience / Education:
- 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
Preferred Experience / Education:
- 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
What can Almac Group offer you?
- 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
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing over 7,500 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. 'Partnering to Advance Human Health' is more than just a tagline - it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group's unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV's not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
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Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.