Administrative Assistant Learner at AbbVie

Key Functions:

In the framework of the Learnership program, the Administrative Assistant provides administrative and clinical management support to the Site Management & Monitoring Clinical Team of Abbvie South Africa and assists the study team in preparing, initiating and managing international clinical studies executed by the South African Affiliate. If applicable, assists with Investigator Site and Vendor Payments according to local Finance processes and Quantum. They key impact of this role is to ensure through their contribution to the local Clinical team, that Site Management & Monitoring fulfills its commitment to the global organization.

Responsibilities:

• The Administrative Assistant (AA) provides administrative and clinical management support to Site M&M personnel and assists them with the in-house organization, management and execution of projects and activities undertaken by Clinical Operations Site Management & Monitoring personnel assigned to clinical studies conducted within the country.
• If applicable, creates a local trial file for the filing of Country specific information. Supports CRAs with the CA and EC submissions of clinical studies and related amendments, including collection of essential documents. Supports CRAs with preparations for PSVs, SIVs, and COVs, as necessary
• Supports local Clinical Team with the handling of Essential Documents, including Contracts and Archiving. Ensure the Investigator Site Files are created, contain the correct and complete documentation, and are shipped as appropriate to Investigator Sites. Internal / External Contacts and Interactions: Uses multiple technologies to maintain open and frequent communication with Site Management & Monitoring personnel. Maintains a positive working relationship with internal / external customers.
• Acts as In-house support for CRAs during site visits (administrative tasks, point of contact etc.)
• Acts as In-house support for CRAs with the handling and destruction arrangements of Investigational Product as, and if, required. This may include the entering of relevant information into Interactive Web-based Reporting Systems. Adheres to applicable country regulations, legal requirements, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs)
• Participates in pre-audit activities to meet both PV and GCP Audit requirements. Supports CRAs to ensure audit and inspection readiness in clinical activities of responsibility. Ensures financial information for assigned studies / sites is entered in a timely manner and is managed in compliance with company policies (ex US). May participate in global Task Forces and Initiatives
• Supports Clinical Team with the processing of Expense Reports and Travel arrangements. Supports with organizing Team Meetings (booking meeting rooms, taking minutes and organizing catering etc.) If appropriate, assists with the filing of training records and other relevant personnel documentation for staff.
• Actively participates in relevant Meetings, manages the collection and distribution of mail and courier requests and may act as a local liaison for CRO (Observational) Studies.
• Assists with other general administrative and organizational matters related to the efficient operation of the SM & M Clinical Team, which may include (but not limited to):

Support with contract administrative tasks:

• Uploads fully executed contracts to Abbvie local/global contract database and provides associated information for global database (OCTUS)
• Proactively supports the clinical team to meet business needs.
• Stationery and office supply orders
• Assisting with critical issue management
• Documenting communication within affiliate staff including taking minutes as required
• Support CRAs with the following items for all SM&M team assigned studies:
• Implement and maintain TMF/eTMF
• Act as a liaison for remote access issues
• Maintains training files and tracks training records
• Supports Managers with the following items:
• Coordinates new employee set up and onboarding (training files)
• May manage travel scheduling, domestic and international, with regards to flights, accommodation, car hire and visa requirements
• May be requested to prepare expense reports

Qualifications:

• Health Sciences qualification
• Proven strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Ability to manage multiple priorities / projects, communication and interpersonal skills, including situations of conflict resolution, problem solving and crisis management. Proactive and positive team player.
• Written and verbal fluency in English and local language (if not English). Familiarity with all standard IT office tools.
• Proven ability to communicate effectively within a multi-cultural / global team environment.
• Exhibits high level of flexibility when facing changes in the work environment
• Ability to create a positive work environment by encouraging mutual respect, innovation, and accountability at all levels