Almac Group is currently seeking a Support and Implementation Engineer for our Lansdale, PA location. The Support and Implementation Engineer, eClinical is responsible for supporting and managing the project delivery of tailored eClinical solutions for our customers. This includes configuring, developing and testing eClinical systems, Requirements documentation, participating in and overseeing the tasks necessary for support of Almac’s client facing eClinical systems.
Responsibilities include but are not limited to:
- Support and Maintenance of eClinical Systems:
- Including, but not limited to:
- Execute specific tasks necessary for the day-to-day support and maintenance of Almac eClinical projects
- Provide hands-on oversight and intervention for clients facing projects in support of Customer Solutions Specialists
- Act as the next point of contact for issues escalated to them by Customer Solutions Specialists
- Perform defined quality checks on maintenance tasks for Customer Solutions Specialists and other Implementation & Support Engineers
- Regularly monitors investigation case queue for new, internally or externally raised issues and service requests.
- Prioritize and re-prioritize workload based on urgency of submitted issues and service requests communicating status regularly.
- Codes configuration and data update scripts as necessary
- Provides workaround where possible while investigating raised issues.
- Provides after-hours support in response to emergency requests on a rotating basis.
- Interpret support requests and translate them into actionable system requirements for the development team.
- Maintain and update the knowledge base and FAQs based on incoming questions and user feedback.
- Including, but not limited to:
- Implementation and Development of eClinical Systems: Ensure eClinical system configuration, access, optimal system set-up and ongoing maintenance of the eClinical systems occurs in line with customer expectations.
- Including, but not limited to:
- System configuration, development, and set-up:
- Understands the Almac product feature-set and uses it to configure and code systems per specifications and in line with departmental standards.
- Create and implement system design based upon critical evaluation and thorough understanding of the specifications.
- Performs system configuration and set-up in line with documented requirements and standards.
- Risk Management actively participates in identifying, mitigating, and managing risk by raising concerns to clients and internal teams as appropriate.
- Acceptance Testing: Perform and Support client user acceptance testing. Participate in any other required implementation activities on a project basis.
- System Access: appropriately established system access based on system requirements and documented standards
- System configuration, development, and set-up:
- Including, but not limited to:
- Design of eClinical Systems: Design eClinical solutions for the clinical trial in collaboration with the customer and internal Almac teams.
- Collect, analyze, organize and write system requirements for both initial and subsequent builds. Ensure proper and clear understanding of requirements by client and internal team members.
- Lead requirements review meetings. Elicit requirements through the use of interviews, document analysis review (protocol, supporting documents, questionnaire specifications), business analysis, and client need.
- Identify key stakeholders and define their responsibilities related to requirements definition, assessment and approval. Communicate with the client and other stakeholders to understand their project objectives.
- Critically evaluate requirements gathered from multiple sources, reconcile conflicts, act as a consultant by providing best practices and lessons learned, and separate user ‘wants’ from true ‘needs’.
- Write clear, concise and detailed system requirements to meet the client’s needs while supporting Almac goals.
- Maintains technical knowledge by attending educational workshops and/or reviewing publications.
- Maintains quality service by following organizational SOP’s, WI’s and standards
- Public Speaking (Department & Client Presentations)
- Identify need for departmental process and tools improvement
- Completes other duties assigned by management.
- Assists in other projects and capacities as requested.
- Assist other departments with tasks that are not listed in this job description.
- Actively works on improving overall skills and abilities through Professional Development Plan
- Volunteers to take on additional tasks as workload permits
Qualifications:
Required Experience / Education:
- Bachelor’s degree OR HS degree and equivalent of 2 years of work experience required either through full time work as a programmer/developer utilizing coding skills
- 1+ years of experience managing multiple projects or tasks simultaneously
- Demonstrated ability to work through escalating issues across sponsor/vendor personnel
- Proficient knowledge of Microsoft Office products, especially Word, Excel and PowerPoint
- 3 + years developing applications utilizing Microsoft SQL
- 3 + years in a client facing role, interacting directly with manager level personnel
- 3+ years 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
Preferred Experience / Education:
- 3+ 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
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.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.
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