[KZL-494] | Clinical Trial Manager

Overview: TFS HealthScience is excited to be expanding our Strategic Resourcing Solutions (SRS) team and we are looking for an experienced, highly motivated Clinical Research Manager who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert. We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver. Our core values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation. Together we make a difference.

What can we offer you? A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.

Responsibilities: The Clinical Research Manager (CRM) is part of Clinical Operations or Strategic Resourcing Solutions Unit within TFS Clinical Development Services and will function operationally as a member of a Project Team being responsible for coordinating and overseeing the country and site management activities during study conduct, according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations. The CRM will be reporting to the Project Manager being responsible for certain aspects of project activities which may include country and site tracking, monitoring plans, review of monitoring reports and study monitoring resources management.

Responsibilities include:

1. Responsible for overseeing all aspects of monitoring and site management activities ensuring compliance with ICH/GCP guidelines, SOPs and protocol requirements.
2. Lead, manage and guide CRAs being responsible for training and quality oversight of site management activities while proactively identifying potential operational issues and ensuring study deliverables.
3. Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.
4. Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.
5. Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.
6. Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.
7. Perform co-monitoring visits as part of the monitoring team quality oversight.
8. Review and approve site visit reports (PSV, SIV, MV and COV) with agreed and act as first point of contact for issue escalation ensuring the proper resolution and action plan definition and follow up.
9. Review CRA Site Visits calendar ensuring monitoring visits (both remotely and on site) are being scheduled and conducted following monitoring plan frequency.
10. Update the Project Manager with status of sites and countries and ensure a proper escalation of any issue detected at site/country level.
11. Ensure documents remain current during the course of the trial and ensure proper maintenance of Trial Master File being responsible of QC when delegated by Project Manager.
12. When delegated by Project Manager, track and approve investigators payments.
13. Assist Project Manager in CRA training program, training CRAs on study procedures and requirements and ensuring a proper handover when there is a replacement of CRA.

Qualifications:

1. Degree in clinical, science or health related field.
2. 4+ years of clinical research experience, preferably as CRA, including relevant on-site monitoring experience.
3. Able to work in a fast paced environment with changing priorities.
4. Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas.
5. Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
6. Ability to work independently as well as in a team matrix organization and multiple projects.
7. Excellent written and verbal communication skills as well as computer skills.
8. Excellent organizational and Line Management skills.
9. Ability and willingness to travel up to 20-30%.

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