CTA position - Pharma/Medical Device
Being a CTA at Fern Valley means becoming part of a group of high quality specialists.
Receiving the possibility to develop yourself as a clinical professional shouldered by our company's five core values, you'll add value to our customers team that goes beyond your scientific and technical skills.
Note that throughout this journey you will never be alone; personal contact, follow-up, training and career planning are of the utmost importance to us.
Everyone at Fern Valley proudly takes up the responsibility of being fair and open towards every partner on our path, as we value them.
- Support during the feasibility process (e.g. preparation and follow-up of Confidentiality Agreements, retrieve completed Feasibility Assessments, complete feasibility tracker)
- Coordinate translations of study documents
- Assist in preparation of submission package to ECs/HA
- Prepare documents for Site Initiation Visits (creation of site specific documents)
- Set-up and distribution of Investigator Site Files
- Set-up of study tracking tools
- Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File to support readiness for audits and inspections
- Logistic management of non-study drug related supplies/services
- Support in local study process, presentations, mailing to sites, newsletters and correspondence
- Assistance in preparation, support during conduct of audits and inspections
- Support and follow-up of local team meetings and local investigator meetings (e.g. attendee list, agenda, meeting materials, writing of minutes)
- Set-up of (e)TMF files and in-house filing of TMF documents in the appropriate files according to the SOP and ICH-GCP and other local guidelines
- Support ongoing use of CTMS by maintaining and tracking relevant activities.
- Minimum of a Bachelor’s Degree is required
- Previous clinical research experience a plus
- Requires previous administrative support experience for at least 1 year
- Knowledge of Good Clinical Practices (GCP)
Demonstrated competencies/skills in the following areas are required:
- Awareness and understanding of cultural differences as well as regional operational differences
- Excellent written and verbal English communication skills
- Interpersonal, decision-making and issue resolution skills
- Effective planning and organization skills
- Computer skills (Microsoft office – Excel, Word and Power Point)
- Attention to detail
- Excellent follow through
- An attractive salary in line with your experience and skills
- Fringe benefits including a medical insurance, pension plan and a care plan
- A supporting environment
- Respect for the life-work balance
- Career planning
- A focus on professional and personal growth through training and coaching
- Room for personal engagement to help shape our company's future