Senior Document Specialist

Premier Research Group Limited
15 Feb 2018
25 Feb 2018
Contract Type
Full Time
Premier Research helps highly innovative biotech and specialty pharmaceutical companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, paediatrics, and rare diseases. We're looking for a talented Senior Document Specialist to join our UK team!

The Wokingham office, Berkshire is actively recruiting for a Senior Document Specialist to join the existing team. This will be an office based position where the successful job holder will oversee the Trial Master File (TMF) to ensure documents are being processed and filed accurately and according to Premier Research Standard Operating Procedures, sponsor requirements, and ICH/GCP requirements. Additional duties include: Ensuring the security and controlled access of the Secure File Room (SFR) for all paper documents. Responsibility for performing a visual QC of all submitted documents for completeness and legibility. Providing required metrics for assigned studies related to documents submitted and processed for managements review. Supporting the development and implementation of policies, procedures and systems relative to the Trial Master File and study documents.


- Ensures all documents are accurately processed in the TMF/eTMF in a timely manner.
- Responsible for deliverables related to the TMF/eTMF as outlined in the in the File Management Plan (FMP)
- Oversees document processing activities for the SFR and manages the timely delivery of documents, filing and archiving for the assigned clinical studies.
- Identifies process and quality improvement needs, supports and/or facilitates the implementation of necessary changes, including system enhancements, as required.
- Supports and drives the continuous improvement and inspection readiness initiatives for assigned studies.
- Reviews essential documentation upon submission to the TMF for legibility, completeness and appropriate identifiers for studies assigned.

- Verifies each document submitted to TMF/eTMF is processed, named & filed according to the FMP placed in the proper location on the TMF/eTMF.
- Performs additional duties and assignments as requested.
- Responsible for coordinating with other departments to ensure all TMF/eTMF storage needs related to ICH-GCP/ISO14155 documentation, per the relevant SOPs and WGs, are prepared and maintained.
- Meets with appropriate Project Team staff for studies assigned at the beginning of the study to ensure understanding of the scope of responsibilities transferred to Premier and anticipated TMF development and maintenance needs.
- In conjunction with the Project Team develops and implements the FMP (in accordance with Premier Research and /or Sponsor SOPs).
- Conducts periodic reviews for assigned studies throughout the project of all sections of the TMF/eTMF, ensure ongoing compliance with applicable regulations and Premier Research's standard operating procedures.
- Prepares documentation at the end of the study for return to the Sponsor in accordance with FMP, Premier Research or Client SOPs and industry standards.
- Provides customer service by maintaining the TMF/eTMF according to the Sponsor agreed FMP, provides information in a timely, efficient and responsive manner.
- Ensures that documents submitted to the TMF/eTMF are accurate, legible and appropriately filed.
- Other:

- Ensures appropriate coaching and training for Project Team members and document specialists related to the TMF/eTMF as required and appropriate to level.
- Trains additional personnel in essential job functions as necessary to maintain continuity as required and appropriate to level.
- Performs additional duties and assignments as requested.

- Qualifications in clinical, science, or health-related field (preferred), or business/office administration

- Experience

- Previous document management experience gained in a clinical research setting
- Experience in Document Control in complex projects or global projects or equivalent experience
- Experience in line management preferred

- Expertise and know-how
- Good computer skills including MS Word, Excel, PowerPoint and MS Outlook
- Knowledge of ICH / GCP regulations
- Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- eTMF/TMF Management Experience
- DIA Reference Module knowledge

- Personal skills & behaviours
- Must be detailed oriented with good organizational skills
- Good communication skills (verbal, written and interpersonal)
- Ability to work independently as well as part of a project team in a matrix organization
- Fluent verbal and written English as well as the local language(s) required
- Excellent team player, collaborative and able to be part of an effective team.
- Ability to multitask and work effectively in a fast-paced environment with changing priorities.
- Accountable, dependable and strong commitment.
- Is customer service focused in approach to work both internally and externally.
- Maintains a positive, results orientated work environment.

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