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Fsp Digital Implementation Manager

2+ years
Not Disclosed
10 Dec. 9, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Digital Implementation Specialist

Location: Flexible
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office


Position Summary

The Digital Implementation Specialist provides support for both study-related and internal operational tasks, focusing on the management and coordination of digital implementation projects. This role involves working closely with internal teams, external vendors, and copyright holders to ensure the smooth execution of single-scoped studies and operational processes.


Key Responsibilities

Digital Implementation Support

  • Manage and support digital implementation projects in collaboration with senior team members.

  • Act as a digital implementation manager for assigned tasks.

  • Coordinate with internal resources, translation vendors, and instrument copyright holders; manage related contracts as needed.

Documentation & Filing

  • Perform eTMF filing and maintain project documents, including meeting minutes.

  • Execute periodic quality reviews to ensure adherence to guidelines.

Training & Coordination

  • Coordinate project training needs and track completion of training and required documentation (e.g., NDAs, security clearances).

  • Schedule and lead project-related meetings, both internal and external.

Project & Risk Management

  • Prepare, review, and finalize project/program plans as per client contracts.

  • Ensure compliance with project parameters, escalation processes, and client expectations.

  • Identify and escalate legal, financial, and operational risks per established procedures.

Vendor & Budget Management

  • Manage external vendors to align with project scope, budget, timelines, and quality standards.

  • Perform intermediate project financial management tasks.

Team Collaboration & Mentorship

  • Provide training and guidance to junior team members.

  • Contribute to internal process improvements and innovation initiatives.


Qualifications

Education and Experience

  • Bachelor's degree or equivalent formal academic/vocational qualification.

  • Minimum 2+ years of relevant experience, preferably in digital solutions or clinical research.

  • A combination of education, training, and related experience may be considered as an equivalency.

Knowledge, Skills, and Abilities

  • Working knowledge of digital solutions in clinical research and basic project management principles.

  • Familiarity with the translation and linguistic validation process.

  • Proficient in managing external vendors and ensuring quality deliverables.

  • Effective communication skills, both verbal and written, with proficiency in English.

  • Strong interpersonal skills with the ability to adapt to dynamic situations.

  • Demonstrated organizational skills with attention to detail and multi-tasking capabilities.

  • Proficient in Microsoft Office Suite (Outlook, Excel, Word, etc.).

  • Cross-cultural awareness with the ability to navigate diverse environments.

  • Basic understanding of clinical research, medical terminology, and therapeutic areas.


Why Join Us?

This role offers a unique opportunity to work on innovative digital implementation projects, contribute to impactful clinical research, and collaborate with a diverse team of professionals. You will gain valuable experience in project management, vendor coordination, and digital solutions, all while fostering professional growth in a supportive environment.

If you’re detail-oriented, organized, and passionate about digital solutions in clinical research, we encourage you to apply!