Global Clinical Trial Operation - Emerging Talent Rotation Associate - Remote

About the position Under the oversight of the line-manager, mentor, and/or rotational assignment manager, this position involves a 24-36 month committed experience rotating throughout Research and Development Division/Global Clinical Trial Operations in various clinical trial functions in preparation for movement into next roles. This role will collaborate throughout Global Clinical Trial Operations local, country, and HQ levels, with trial management, data management, country operations and other areas. This role will rotate through various organizations, teams, and functions within Research and Development Division and Global Clinical Trial Operations to gain broad clinical research exposure and experience in support of clinical trial execution. The role assists in meeting Site Ready objectives, IRB/ERC and Health Authorities submissions, study execution objectives, data management responsibilities, clinical /non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable, in support of clinical trial delivery. Responsibilities may include, but are not limited to: Trial and site administration and management: Track essential documents and report issues as applicable Ensure collation and distribution of study tools and documents Update clinical trial databases (CTMS) and trackers Clinical supply & non-clinical supply management, in collaboration with other country roles Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable) Document and data management: Prepare documents and correspondence Collate, distribute/ship, and archive clinical documents, e.g. eTMF Assist with eTMF reconciliation Execute eTMF Quality Control Plan Update manuals/documents Document proper destruction of clinical supplies. Prepare Investigator trial file binders Obtain translations of documents Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to: In a timely manner, provide and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions Obtain, track and update study insurance certificates Support preparation of submission package for IRB/ERC and support regulatory agencies submissions. Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives to: Maintain contracts (e.g. CTRAs) Track and report contract negotiations Update and maintain contract templates (in cooperation with Legal Department) Monitor and track adherence and disclosures Maintain tracking tools Obtain and process FCPA documentation in a timely manner Meeting Attendance & Planning: Organize meetings (create & track study memos/letters/protocols Support local investigator meetings where applicable

Responsibilities

• Trial and site administration and management: Track essential documents and report issues as applicable
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Clinical supply & non-clinical supply management, in collaboration with other country roles
• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)
• Document and data management: Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Assist with eTMF reconciliation
• Execute eTMF Quality Control Plan
• Update manuals/documents
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders
• Obtain translations of documents
• Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to: In a timely manner, provide and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives to: Maintain contracts (e.g. CTRAs)
• Track and report contract negotiations
• Update and maintain contract templates (in cooperation with Legal Department)
• Monitor and track adherence and disclosures
• Maintain tracking tools
• Obtain and process FCPA documentation in a timely manner
• Meeting Attendance & Planning: Organize meetings (create & track study memos/letters/protocols
• Support local investigator meetings where applicable

Requirements

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
• Proficient IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role
• Effective time management, organizational and interpersonal skills, conflict management
• Effective communication with external customers (e.g. sites and investigators)
• High sense of accountability / urgency.
• Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• Works effectively in a matrix multicultural environment.
• Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to customer focus, both internally and externally.
• Able to work independently
• Proactive attitude to solving problems / proposing solutions
• Clinical Research, relevant healthcare or transferrable experience/skills preferred.
• High School Diploma or equivalent with completed job training (office management, administration, finance, life sciences, engineering, project management, healthcare, education preferred) required.
• Bachelor's Degree preferred.
• Adaptability
• Clinical IT
• Clinical Research Management
• Clinical Study Design
• Clinical Trial Agreements (CTA)
• Clinical Trial Compliance
• Clinical Trial Management
• Clinical Trials
• Contract Lifecycle Management (CLM)
• Contract Management
• Customer-Focused
• Data Analysis
• Data Management
• Document Management
• Good Clinical Data Management Practice (GCDMP)
• ICH GCP Guidelines
• Medical Research
• Medical Supply Management
• New Technology Integration
• Office Administration
• Project Management
• Regulatory Compliance
• Regulatory Submissions
• Supply Change Management

Apply tot his job Apply To this Job