Clinical Trials Facilitator
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Position Overview & Specifications
- Facilitate the collection and preparation of documentation required to confirm local capacity, obtain R&D theme lead approvals, collate regulatory approvals needed to instigate clinical trials
- Facilitate the collection of local and regulatory approvals required for the review and implementation of amendments
- To work closely with Finance and Research Teams to ensure the timely invoicing of commercial trials
- Provide comprehensive advice to external and internal parties for the conduct of clinical trials across the partner organisations.
- To assist in maintaining records of the clinical trials portfolio of the partner organisations
- To ensure that trails metrics are collected to permit tracking of milestones and, where appropriate, to coordinate the triggering of invoicing to sponsors.
- To assist int he archiving of clinical trails and documentation to meet prevailing regulatory requirements.
- To ensure MATTS (MedSciNets Active Trial Tracking System) end EDGE requirements are met
- To maintain a working knowledge of prevailing regulations, guidance, best practices and GCP standards regarding the conduct of clinical trials
- To ensure confidentiality of commercially sensitive information
- To ensure data protection imperatives are respected
- To undertake such other duties within the scope of the post as may be requested by the SCTF
- Strong planning and organisational skills including the ability to prioritize and manage multiple tasks
- Excellent interpersonal skills - tactful and able to deal with a wide range of people in an enthusiastic and helpful manner whilst being capable of firmly maintaining polices and regulations
- Problem soloing skills - pragmatic and flexible approach whilst maintaining policies and regulations
- Strong computer skills (proficient with MS WORD, Excel and web - based applications)
- Commitment to quality culture
- A professional demeanor and high ethical standards
- A proactive approach
- Ability to understand function in the different cultural environments of academics and clinical academia
- experience acquired in administration role(s), preferably in either a pharmaceutical industry of clinical research setting
- Understanding of medical terminology and practice
- Knowledge of GCP and full working knowledge of local regulatory requirements for the conduct of clinical trials
- Understanding of Ethics committees and competent authority approval processes
- Specific experience of clinical trial administration
Candidate Selection & Onboarding Process
Application & Resume Screening
Submit your tailored CV/Resume directly to the talent acquisition portal.
Technical & Competency Interviews
Virtual interviews with the hiring manager and multidisciplinary team.
Formal Offer & Benefits Negotiation
Written agreement outlining compensation, equity, retirement vesting, and relocation allowances.
Onboarding & Corporate Integration
Equipment provisioning, team orientation, and commencement of duties.
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