Senior TMF Officer (2 years)

Geneva, Switzerland
[Closing date: 26 March
2019]

 

Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for Neglected Diseases (www.dndi.org)

The DNDi NTD initiative is dedicated to the clinical development and access plans for the 5 following neglected tropical disease areas: human African trypanosomiasis, leishmaniasis, Chagas disease, filarial diseases, and mycetoma. The initiative is responsible for designing the strategy, conducting and reporting the research, as well as ensuring resources and managing budget from phase 1b/proof of concept up until policy change. The team is equally based in Geneva office as well as well as in our offices located in Africa, Asia, and South America.

 

Purpose of the position

The Trial Master File Management Senior Officer is responsible to compile, maintain and archive all TMF related documents in order to prepare the submissions to any international authorities and to comply with GCP requirements for filing and archiving of clinical trials. S/he will plan and coordinates the overall management of the Trial Master Files and associated processes following GCP and ICH, including system and tool development, business process documentation and is ultimately responsible to ensure inspection readiness for the TMF across the initiative.

 

Specific job responsibilities

  • Create a TMF Index in collaboration with Quality department
  • Manage document control processes and systems for GCP activities in compliance with internal procedures and policies and ensure compliance with ICH/GCP and relevant international and local legislation and regulations
  • Assess suitability of documentation for filing (accuracy, completeness, and legibility)
  • Archive clinical trial documents
  • Manage the user administration and conduct training of the Trial Master File/eTrial master file process
  • Ensure high quality Trial Master File set-up and management (on-boarding of study contributors, completion of the Trial Master File management plan, study specific preparation of documents in the system, periodic reviews, etc.)
  • Serve as a Trial Master File contact for documentation to the project team and cross functional departments 
  • Follow up on open record management queries and ensure their full resolution
  • Assist in periodic Trial Master File audits
  • Plan and perform internal periodic quality check activities of the Trial Master File, provide findings to the clinical team and provide support to the team to ensure compliance is maintained to meet internal and external quality standards
  • Provide support to clinical teams during regulatory inspections for record organization and retrieval
  • Act as the Subject Matter Expert for the Trial Master File process, ensuring that project documentation is maintained to the highest level of quality and compliance while aligning with company and departmental objectives
  • Continuously monitor, identify, and report quality problems and record management work practices, make recommendations for resolutions, and initiate actions required to resolve quality and efficiency problems

 

Job requirements

Experience

  • Experience: minimum 6 years work experience on a similar position, managing TMF and electronic TMF
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in public and private sector is highly desirable

Skills and attributes

  • Very good knowledge of regulatory (GCP, GLP and GMP) particularly in TMF management
  • Very strong technical writing skills (procedures, protocols, and reports)
  • Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
  • Clear and systematic thinking that demonstrates good judgment and problem solving competencies
  • Very good communication skills in multicultural, multi-lingual environments
  • Ability to work effectively as part of a multicultural team
  • Well organized and structured
  • Very good analytical skills
  • Ability to contribute to the project delivery under minimum supervision
  • Ability to manage middle sized projects with budget management under supervision
  • Provide specialist services to operational line or project team
  • Ability solve non-routine problems on a case by case/project basis

Education

  • Graduate or post graduate degree

Other requirements

  • Fluency in English
  • Proficiency in local languages desirable
  • Very good ability with IT tools

 

Other information

  • Status: full time – temp. role for 2 years

 

To apply

  • Deadline for application: Accepting applications until 26 March 2019
  • Only shortlisted candidates will be contacted