Senior Site Activation Specialist
1 month ago
Senior Site Activation Specialists perform tasks at a country level associated with Site Activation SA activities in accordance with applicable local and/or international regulations, standard operating procedures SOPs, project requirements and contractual/budgetary guidelines.
Developing professionals work under moderate oversight and supervision, responsible for making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area.
- Single Point of Contact SPOC for assigned studies, ensuring adherence to standard operating procedures SOPs, Work Instructions WIs, quality of designated deliverables and project timelines.
- Perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions.
- Prepare site documents, reviewing for completeness and accuracy.
- Review, track and follow up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form ICF, and Investigator Pack IP release documents.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines, ensuring monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- Engage with sponsors during start-up as needed.
- Gather regulatory intelligence.
- Maintenance activities.
Required Knowledge, Skills and Abilities:
- Bachelor's Degree in Life Science or related field.
- Minimum 3 years' prior experience in life sciences or similar, with experience in a leadership capacity considered advantageous.
- Fluent/native language capabilities, including English.
- Good negotiating and communication skills with ability to challenge.
- Ability to handle change and ambiguity.
- Ability to work on multiple projects.
- Knowledge of applicable functional/regulatory requirements, including local regulations, SOPs and GCP/ICH.
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