Current jobs related to Tmf Document Specialist - Bloemfontein - IQVIA
-
Document Specialist I
16 hours ago
Bloemfontein, South Africa Parexel Full timeThe Document Specialist I will provide document technology support on Medical Writing projects as appropriate. Some specific responsibilities include compilation of appendices to clinical study reports and similar documents, document formatting and post PDF work, document scanning/uploading, preparation of electronic appendices using departmental publishing...
-
Clinical Data Associate
10 hours ago
Bloemfontein, Orange Free State, South Africa IQVIA Full timeBase level rolePerform comprehensive data management tasks including data review, query generation and query resolution. This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data Review Model, testing of data validation rules, etc. Data Management tasks should be inclusive of Study Start-up,...
-
Clinical Data Associate
2 weeks ago
Bloemfontein, South Africa IQVIA Full timeBase Level Role Perform comprehensive data management tasks including data review, query generation and query resolution. This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data Review Model, testing of data validation rules, etc. Data Management tasks should be inclusive of Study...
-
Clinical Data Associate
2 weeks ago
Bloemfontein, South Africa IQVIA Full timeA global clinical research provider is seeking an individual for a role involving comprehensive data management tasks focused on clinical trials. The ideal candidate should have a Bachelor’s degree in a relevant field, significant experience in data management, and proficiency in Rave systems. This position requires ability to work in diverse teams and...
-
Clinical Data Associate
2 weeks ago
Bloemfontein, Orange Free State, South Africa IQVIA Full time R550 000 - R850 000 per yearAdvance level roleProvide timely status updates including issues & risks to DM and DMLs as neededAct as the Point of contact for Clinical Data Manager, working pro-actively to identify risks and provide mitigationsMay communicate with the vendors to resolve reconciliation issues.Provide input to Study set up activities including but not limited to creation...
-
Clinical Data Associate
1 week ago
Bloemfontein, South Africa IQVIA Full timeBloemfontein, South Africa | Full time | Hybrid | R1517767 - **Job available in additional locations** Advance level role - Provide timely status updates including issues & risks to DM and DMLs as needed - Act as the Point of contact for Clinical Data Manager, working pro-actively to identify risks and provide mitigations - May communicate with the vendors...
-
Clinical Data Associate
1 week ago
Bloemfontein, South Africa IQVIA Full timeBloemfontein, South Africa | Full time | Hybrid | R1468141 - **Job available in additional locations** Base level role** - Perform comprehensive data management tasks including data review, query generation and query resolution.This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data...
-
Clinical Data Associate
2 weeks ago
Bloemfontein, South Africa IQVIA Full timeAdvance level role Provide timely status updates including issues & risks to DM and DMLs as needed Act as the Point of contact for Clinical Data Manager, working pro-actively to identify risks and provide mitigations May communicate with the vendors to resolve reconciliation issues. Provide input to Study set up activities including but not limited to...
-
Clinical Data Associate
2 weeks ago
Bloemfontein, South Africa IQVIA Full timeBase level role Perform comprehensive data management tasks including data review, query generation and query resolution. This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data Review Model, testing of data validation rules, etc. Data Management tasks should be inclusive of Study...
-
Bloemfontein, South Africa IQVIA Argentina Full timeJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with...
Tmf Document Specialist
2 weeks ago
**Job Overview**
Provide Trial Master File (TMF) - Quality checks related assistance to study teams.
Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics.
Ensure that project timelines are met and facilitate the orderly imaging, transfer, retention, and disposition of various project-related and business records. Administer records management systems.
**Essential Functions**
- Perform assigned complex administrative tasks to support team members with project execution
- Assist in updating and maintaining complex data in systems within project timelines and per project plans
- Coordinate the retrieval of records requested by users and prepare closed studies to final destination within agreed timelines
- Conduct and manage scanning processes and train staff on scanning processes
- Interface with departments to support retrieval projects and ensure information needs are met
- Serve as primary contact for internal/external clients
- Monitor and review filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs) where applicable
- Maintain records center security to protect record integrity by ensuring compliance to SOPs
- May coordinate transfer, recall, and disposition of records to commercial records storage centers
- Oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment
- Train team members on records management tasks, policies, and procedures
- Establish and maintain effective internal and external client communications
- Design and administer records management systems and processes
- Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs
- May function as team leader for records management projects
**Qualifications**
- Bachelor's degree or equivalent
- 3-4 years' experience working in relevant clinical research environment. Equivalent combination of education, training and experience.
- Good knowledge of applicable clinical research regulatory requirements, i.e., International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines;
- General knowledge of computer technology and software programs, and accurate data entry skills.
- Attention to detail and accuracy in work.
- Ability to achieve productivity despite time pressure constraints.
- Good problem-solving skills.
- Strong organizational, planning, and decision-making skills.
- Good time management and prioritization skills.
- Extensive knowledge of records management laws and regulations.
- Excellent oral and written communication skills including good command of English language.
- Ability to manage and lead others.
- Ability to establish and maintain effective working relationships with internal and external clients.
- Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
- Position is required to stand, walk, sit, use hands to manipulate, handle or feel, and reach with hands and arms.
- Position is required to stoop, kneel and may need to utilize a ladder for paper files on high-density file systems.
