About the vacancy
Clinical R&D
About Your Next Job
You will be accountable for managing the clinical operation activities for clinical studies. This person will be key in driving the clinical studies day to day activities, ensuring on time delivery of main clinical milestones, as well as respect of GCP. Focus will be on EU Submission.
About Your Next Colleagues
We are experienced professionals that love to vibes of a startup to make things happen. We have a pragmatic approach.
About Your Tasks and Responsibilities
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Responsibilities - Lead, manage and co-ordinate the conduct of assigned clinical trials
from study start-up to close out in accordance with ICH-GCP - Oversees the quality of the clinical operations for the studies he/she is in charge of - Ensure that study is Inspection ready through the study lifecycle and
partake in CAPAs when needed - Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables o Collaborates with Clinical Science, data management and statisticians ensuring data base maintenance, interim and final database locks. o
Manages clinical sites and
academics institutions, ensures adherence for keeping clinical records,
source documents, data entry, manages clinical trial logistics, applications
(IRB, local agencies) - Planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables - Ensuring implementation and conduct of study(ies) in accordance with ICH-GCP guidelines o Ensures development, review, finalization and delivery of high quality key study documents in order to meet study timelines. o Manages CRFs creation, implementation, collaborating closely with data management for the study activities o Ensures accurate maintenance and archiving of study records o Oversees TMF - Management of study budget and timelines - Management of vendors, including a CRO, to the required standards |
About Your Skills and Experience
- BsC in life sciences
- Msc/PhD in life sciences is a plus
- Excellent organisational and communication skills;
- ‘Can-do’ attitude and willingness to be flexible
- Minimum of 8 years’ experience in clinical Operations management within biotech or pharma setting.
- Experience & knowledge of clinical project management
- Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
- Understanding of regulatory environment, GCP/ICH, Inspection readiness
- Experience working in an orphan disease field is a plus
- Strong communication and interpersonal skills, with the ability to collaborate effectively across diverse functional areas.
Only apply if...
We can offer this position as a contractor, for a duration of 6 months, There is a real chance that the contract will be extended. You should ensure that you are allowed to work as a contractor. You should be Europe based.
You are eligible to work in EU
We only accept applicants who are eligible to work in the EU
Contact person
Alice Stuurman
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JCR Pharmaceuticals Co., Ltd. is a fully integrated specialty Biopharmaceutical company focusing on the treatment of rare diseases including growth hormone deficiency, anemia, graft-versus-host disease, Fabry Disease and Mucopolysaccharidosis Type II. Founded in 1975 and headquartered in Ashiya, Hyogo prefecture, JCR has around 900 employees, with biomanufacturing sites and research centers in Kobe (Japan), and overseas subsidiaries in San Diego (USA), Leiden (Netherlands), and Sao Paulo (Brazil).