Country Study Startup Specialist

2 months ago

Mascot, Australia ABBVIE Full time

**What you'll be doing**
- The Clinical Project Assistant (CPA) provides administrative and clinical management support to Site M&M personnel and assist 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 original documentation. Supports CRAs with the CA and EC submissions of clinical studies and related amendments, including collection of essential documents. Supports CRAs with translation of Clinical Study documents and local Clinical Team with preparations for PSVs, SIVs, and COVs, as necessary.
- Supports local Clinical Team with the handling of Essential Documents, including Contracts and Archiving. Ensures the Investigator Site Files are crated, contain the correct and complete documentation, and are shipped as appropriate to the Investigational 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.
- May be assigned as the local updater of databases (such as IMPACT) with Country related data, if applicable. If applicable, assists in forwarding safety information to the appropriate group. In-house support for CRAs during site visits (administrative tasks, point of contact etc.)
- Acts as in-house support for CRA’s 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 assigns studies/sites is entered into company systems 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.
- If applicable, supports relevant Line Managers with the onboarding process of new staff. Supports Affiliate Clinical Team with the updates to local SOP’s and Work Instructions, when applicable. 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.
- May interface with and build professional collaborative relationships with:Local personnel including Medical Department personnel and other AbbVie personnel within Clinical Operations as well as Safety Representatives, Regulatory, Finance and Legal Functions, Human Resources, administrative staff and other relevant functional areas.
- Site Management and Monitoring personnel in other Countries and Document Management.External service providers-Study personnel (investigators, study coordinators, pharmacists, etc.)-Peers within the organization vendors.

**Some experience that will help you get started**
- Preferred background in life-science or health-care related qualification or experience is desired
- Preferred with a proven track record of success in a Site M&M Department and a basic knowledge related to ICH/GCP Guidelines and applicable local regulations.
- Basic awareness of the conduct of clinical trials and its associated activities and responsibilities.
- Previous administrative experience is desired.
- Proven negotiating skills, tact and diplomacy.
- 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.

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