Join a leading Pharma Client as a Senior Site Activation Specialist!
Job Overview
We are seeking an experienced Senior Site Activation Specialist to support clinical studies from site selection through site activation and startup activities. You will play a key role in managing regulatory, ethics, and contractual submissions while ensuring compliance with ICH-GCP guidelines, local regulations, study requirements, and project timelines. This is an excellent opportunity to work remotely within a fast-paced and collaborative clinical research environment.
- Location: Remote
- Contract Length: Until 21 December 2026
- Start Date: ASAP
Key Responsibilities
- Act as the primary point of contact (SPOC) for investigative sites, Site Activation Managers, project teams, and key stakeholders.
- Coordinate and execute site startup and activation activities in line with study timelines, SOPs, and regulatory requirements.
- Prepare, review, and manage site regulatory documentation, ensuring compliance, accuracy, and completeness.
- Support regulatory and ethics submissions, including informed consent form (ICF) adaptations and responses to authority queries.
- Conduct quality control reviews of regulatory documents, investigator documentation, and submission packages.
- Track approvals, submissions, document execution, and site activation milestones to ensure timely study startup.
- Maintain accurate records within CTMS, TMF, eTMF, and clinical study startup tracking systems.
Key Requirements
- Bachelor's Degree in Life Sciences or a related discipline.
- Minimum 3 years' clinical research experience with a focus on study startup, site activation, or clinical operations.
- Strong knowledge of clinical trial startup processes, regulatory requirements, ethics submissions, and ICH-GCP guidelines.
- Experience working within CRO and/or Sponsor environments.
- Hands-on experience with CTMS, TMF/eTMF, and study startup tracking systems. xgikmsk
- Excellent organisational, communication, stakeholder management, and problem-solving skills.
Additional Information
- Interview Process: 1-Stage
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