Job Description

A global pharmaceutical company has a 12 month contract position for a Clinical Administrative Assistant (Learner).
Job Summary:
The Administrative Assistant provides administrative and clinical management support to the Clinical Site Monitoring Team and assists the study team in preparing, initiating and managing international clinical studies conducted by the South African Affiliate. 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.
Key Responsibilities:

• The Administrative Assistant (AA) provides administrative and clinical to the local team with the in-house organization and execution of projects and activities undertaken by Clinical personnel assigned to clinical studies conducted within the country.
• Supports CRAs with the CA and EC submissions of clinical studies and related amendments, including collection of essential documents.
• Supports Country Submission specialist (CSS) with collection, tracking and performing quality review of documents for submission to SAHPRA and EC
• Support CSS with preparation of submission letters and forms using available templates and guidance.
• Supports local Clinical Team with the handling of Essential Documents, preparing files and packages to sites.
• 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.
• Adheres to applicable country regulations, legal requirements, Good Clinical Practices (GCPs), ICH Guidelines, (SOPs)
• Participates in pre-audit activities to meet Audit requirements.
• Supports CRAs to ensure audit and inspection readiness in clinical activities of responsibility.
• May participate in global Task Forces and Initiatives
• Supports with organizing Team Meetings (booking meeting rooms, taking minutes and organizing catering etc.)
• Actively participates in relevant Meetings, manages the collection and distribution of mail and courier requests
• Assists with other general administrative and organizational matters related to the efficient operation of the CSM Team, which may include (but not limited to):
• Proactively supports the clinical team to meet business needs.
• Stationery and office supply orders
• Documenting communication within affiliate staff including taking minutes as required
• Supporting and tracking of regulatory and Ethics Documents
• Support CRAs with the following items for all CSM 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 preparation
• May manage travel scheduling, domestic and international, with regards to flights, accommodation, car hire and visa requirements
• May be requested to prepare expense reports

Education & Experience

• Appropriate life-science or health-care related qualification or equivalent work experience.

Essential Skills, Experience, and Competencies

• 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 level.

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com
Should you receive no feedback within 7 days, please accept your application as unsuccessful.