Country Study Specialist
Lucy Stendall at CK Clinical is recruiting for a Country Study Specialist to join a company in the pharmaceutical industry at their site based in Hertfordshire on a contract basis.
The main purpose of the role will be to:
- The Country Study Specialist (CSS) is responsible for providing project co-ordination and operational solutions to support Country Study Managers (CSMs) and to provide clinical trial oversight to local study teams to enable effective management of both global and local trials.
- Identify, develop and maintain operational templates and tools based on the needs of assigned studies.
- Ensure appropriate tracking systems and tools are in place to ensure compliance to regulations, internal policies, ICH-GCP and GPP (when applicable).
- Be responsible for the co-ordination and oversight of local affiliate study level audit/inspection audit action plan activities.
- Build and maintain effective working relationships with local study team members and study site staff.
- Provide input into project management and monitoring plans.
- Coordinate study or country communication plan, budget and payment plan based on country financial plan.
- Ensure trial management tracking tools are updated in a timely manner to ensure systems are accurate.
Further responsibilities will include:
- Proactive contribution to study start-up and patient recruitment strategies and activities to support efficient trial management.
- Proactive study communication via development and distribution of affiliate newsletters for investigators and Local Study Teams, as required.
- Managing shared study area/s according to the company's standards.
- Responsibility for oversight of study-related supplies.
- Supporting CSM(s) by ensuring that monitors have site recruitment plans, that site activations occur according to planned timelines and there is timely closure of non-productive sites.
- Coordinating/executing local investigator and local study team meetings where required.
- Acting as a single point of contact for study CRO monitors for monitoring related activities.
- Providing feedback to local vendor management on performance of CTM CRO staff as required
- Managing country-level Trial Master File (TMF) and review for quality.
- Ensuring database lock activities are within timelines in collaboration with CSM.
- Providing feedback of local suppliers/vendors to vendor manager.
- Ensuring local drug label review and approval is conducted to country requirements.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- University Degree or equivalent preferably in a medical/science-related field.
- Prior work experience demonstrating knowledge and understanding of clinical trials.
- Previous experience managing projects is desirable.
- Experience working as part of a team with a proven ability to make an active contribution to the team's performance and teamwork.
- Able to prioritize and manage multiple tasks with high flexibility.
- Proven project management skills to work with a variety of different systems and stakeholders and deliver commitments on time and with quality.
- Self-motivated and displays initiative/resourcefulness.
- Ability to work independently with limited supervision.
- Strong attention to detail.
- Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.
- Availability to travel domestically and internationally if required.
For more information or to apply for this position, please contact Lucy Stendall on 01246 457733 or email on firstname.lastname@example.org Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL35016 in all correspondence.