(Senior) Site Managers (CRA) - Early Development (m/f)
Full-time (1 FTE)
inVentiv Health Clinical are currently recruiting for dedicated and motivated CRAs with previous clinical research experience in Germany to work Home Based in Germany. When not site monitoring, you will be working on studies for a global Pharmaceutical client, playing an integral role within an established team.
inVentiv Health: Work Here. Matters Everywhere.
This is a great opportunity for someone looking to work on oncology, neurology or immunology studies as a sponsor-based CRA.
A Site Manager (Clinical Monitor) is the person in Early Development & Clinical Pharmacology (ED&CP) of the sponsor that serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of early development and/or clinical pharmacology studies. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site/lab assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out.
* Participates in site/lab assessments, pre-trial site assessment visits and/or study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team
* Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and TA staff regarding study progress and issue resolution.
* Attends/participates in investigator meetings as needed.
* Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
* Ensures site staff have current GCP and necessary protocol and compound training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed internally.
* Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
* Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
* Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
* Ensures site staff complete the data entry and resolve queries within expected timelines.
* Ensures accuracy, validity and completeness of data collected at trial sites
To apply for this position you must have previously worked as a Clinical Research Associate / CRA in Germany (at least one year of monitoring experience), hold a German passport or valid German work visa, speak fluent German and English and be willing to work home-based in Germany.
* 4-year University degree in Life Sciences, Nursing, or related scientific field is required.
* Experience in monitoring Phase I studies is preferred.
* A minimum of 1 year of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
* Good working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
* Willingness to travel with occasional/regular overnight stay away from home depending on the region.
* Proficient in speaking and writing the country language and English. Good written and oral communication skills.
* Ability to work on multiple trials in parallel in different disease areas
There are many benefits available to employees of inVentiv. They include highly competitive compensation and benefits including: 30 days annual leave, life insurance, accidental death and disability cover and bonuses! The position is offered through a contract of employment with inVentiv Health Clinical.
If you have the required experience for this position and are eligible to work in Germany then please apply or contact Andreas Schulz on +49 (0)30 345 069 11.
If this role is not suitable for your experience but you have worked in clinical research in the industry and would like to discuss other roles, please contact a member of the inVentiv Health Clinical team on +49 (0)30 345 069 11.
To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 15,000 employees and the ability to support clients in more than 90 countries, our global scale and deep therapeutic expertise enable inVentiv to help clients successfully navigate an increasingly complex environment.