- Our company is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics.
- Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.
- For the expansion of our team, our company is looking for an experienced Clinical Study Manager.
- He/she will be responsible for all operational aspects of the assigned clinical studies from initiation till closure of the studies.
- The successful candidate will have clinical study operational experience in phase I, II and III drug development phases and is an operational expert in the clinical study activities from start-up, execution until closure and its underlying activities.
- The CSM will be the “operational clinical study voice” for the assigned studies, both internally and externally, he or she is owning the timelines of a clinical study project and is accountable to keep the study on track.
- The successful candidate will excel in establishing good and effective internal and external working relationships.
The Clinical Study Manager will have the following key responsibilities:
- The CSM is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure. The study responsibilities include:
- Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan
- Leading CRO contracts negotiations together with the company vendor manager
- Providing input into and/or developing study related materials such as Clinical Protocol, Clinical
- Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms
- Overseeing and tracking patient recruitment and pro-actively identifies ways to prevent recruitment delays
- Ensuring that study Trial Master File is maintained and up to date
- Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislation
- Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered
- Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained
- Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of Med-watch reports to FDA, EMEA and other applicable regulatory authorities
- Ensuring timely SAE reporting to the responsible IRB and Competent Authority agencies according to the applicable (local) legislation.
- Establishing and maintaining good relation with clinical site and study personnel
- Co-monitoring CROs personnel upon predefined plan
- Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to
- Leading and guiding the internal clinical study team and chairs study team meetings
- Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals
- Preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan and quality in line with the company quality standards
- Responsible and contact person during inspections/audits for the assigned studies
The CSM will also participate in activities other than study-related which include but are not limited to:
- Providing input to the clinical development strategy/plan
- Co-writing/maintaining SOPs within the Clinical Operations department
Desired Skills and Experience:
- Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study
- Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, eCRF databases)
- A competitive salary package with extensive benefits
- A work environment in a human-sized, dynamic, rapidly growing biotech company