Site Activation Operations Assistant
- Experience Level
- Experienced (non-manager)
We are seeking a Site Activation Operations Assistant to join our growing team. The role can be based in Serbia, Ukraine, Russia or Poland.
The Site Activation Operations Assistant I provide general and project specific administrative support to Regulatory Affairs, Site Contracts and Site Activation groups.
Tasks may include but are not limited to:
- Assist with the coordination of translation of regulatory correspondence and submission documents such as protocols, synopsis, ICF and labels
- Pack and dispatch regulatory submissions, site contracts, and site documents follow up for delivery confirmation, obtain and file acknowledgment receipts and update relevant tracking tools
- Perform administrative QC of regulatory submissions and site contracts to ensure correct completeness and formatting
- Liaise with Finance requesting fee payment to Regulatory Authorities.
- Coordinate Contracts signatures by Worldwide authorized personnel, where applicable
- Entering Payee Details from Executed Clinical Trials Agreements in PayFlow
- Ensure department specific study files are submitted to Central Records and audit ready at all times
- Manage the tracking of original site contracts delivery to Worldwide Central Archive and/or Sponsor
- Prepare and submits hardcopies or electronic copies of site essential documents for storage at Central Records.
- Support Business Development activities by archiving emails and assisting with generation of slides
- Provide admin support to Country Intelligence pages and database
- Liaise with third-party vendors such as printing, courier and translation service providers
- Provide general administrative assistance for the smooth running of the department – organize meetings and record minutes, manage diaries, assist with process improvement initiatives
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Clearly, proven organizational and time management skills
- Good written and verbal communication skills to clearly and concisely present information
- Efficient interpersonal skills in a fast-paced, deadline-oriented and changing environment
- Ability to handle multiple tasks
- Good self-motivation skills
- Willingness to adapt to new procedural requirements.
- Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
- Previous administrative experience ideally within the pharmaceutical industry