This position involves defining, developing, maintaining and delivering, standard and custom, instructor-led software courses to clients, partners and employees. The ability to create high quality training materials is key to this position. This role also designs, develops, configures and implements software for clinical studies and works with clients to provide design and configuration recommendations. The position involves working closely with internal and external multidisciplinary teams involved in clinical trial management. Life sciences industry experience and knowledge of the clinical trial process is required.
Self-motivated, resourceful, logical thinker, organized and structured working style, commitment to high quality service delivery and attention to detail, dependable, strong work ethic, positive attitude, team player and customer oriented.
- Responsible for becoming a subject matter expert in multiple Anju Software eClinical product suites and how they are used in the field in different phases of clinical research.
- Responsible for ensuring training participants can effectively use, administer and configure Anju Software eClinical products at the conclusion of the training.
- Increase (internal and external) client satisfaction by delivering high quality course materials and instruction.
- Responsible for ensuring training environments are ready and functioning properly prior to instructor led classes and owns the administration and management of assigned courses (registration, logistics, attendance, setup, assessments, etc.)
- Mentors and coaches training participants
- Responsible for designing, developing, and updating course materials for in-person and web-based, instructor-led training.
- Represents Anju Software in a highly professional manner at client meetings.
- Contributes to the continuing development of product functionality by submitting enhancement requests, communicating client feedback and participating in user testing.
- Applies knowledge of Good Clinical Practices (GCP) and industry guidance to customer deliverables.
- Works with clients to define and recommend improvements for study specifications and study design.
- Translates study requirements, based on clinical trial protocols and other customer provided requirements, into study design specifications.
- Builds and tests eCRFs, edit checks, custom data exports, custom functions, imports, etc. as required to deliver a fully functional data capture solution.
- Unit tests programming and configurations prior to delivery to Anju Quality Assurance team.
- Configures complementary software used to run clinical trials.
- Creates and maintains documentation according to Anju Software standards regarding source code, specification documentation, process control, training curriculums and records.
- Supports Compliance with developing and improving SOPs and Work Instructions and contributes to improvement of training and study build practices.
- Assist in escalated support issues as needed.
- Assists in other training and clinical development tasks as assigned.
- Ability to write clear and concise instruction materials
- Proficiency in Microsoft Office tools
- Excellent oral and written communication skills and presentation skills
- Demonstrated ability to work with all levels within the organization
- Ability to review and interpret clinical trial documentation
- Ability to work independently with minimum supervision
- Organized working style with attention to detail, accuracy and high quality
- Excellent interpersonal skills necessary to maintain positive relationships with clients, partners and employees
- Bachelor’s degree with a major in computer science, life sciences, education, or equivalent
- 2-5 years’ experience delivering training on software products
- Experience in a clinical programmer/study builder/EDC developer position
- A good understanding of data management principles, database structure and the pharmaceutical industry
- Direct experience with EDC and other applications designed with 21 CFR part 11 compliance
- Proven ability to manage multiple projects simultaneously in a deadline driven process
- Ability to travel as needed to deliver training (typically Less than 20% travel required; may include international travel in the future)
- Ability and willingness to work beyond standard work hours as necessary
- Experience with product life cycle development in a .net web based environment would be ideal
- Experience in phase I clinical trials is an asset
- Working knowledge of CDISC standards and SDTM implementation is an asset
- Experience building studies in TrialMaster product suite is an asset.
The Department Head has the discretion to hire personnel with a combination of experience and education which may vary from the above listed qualifications.
Job Type: Full-time
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
- Monday to Friday
- Fully Remote
Work Location: Remote