Clinical Trials Manager, Inflam/Resp
A vacancy has arisen for a Clinical Trials Manager, Inflam/Resp with an internationally renowned pharmaceutical company, based in their California office. This organization is known for its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. This is an exciting opportunity to work with a leading pharmaceutical organization and support their innovative impact on the healthcare field.
- Critically evaluating scientific proposal or protocol and budget for clinical operation feasibility and fair market value assessment.
- Establishing strong partnerships with external investigators and collaborators to ensure ongoing activities (e.g. sponsor updates, drug shipments, publications, milestone payments, etc.) for CO and ISR studies are executed in a timely manner and with high quality.
- Establishing strong cross-functional relationships and exhibiting strong leadership skills with counterparts in other functional teams (e.g., CSM, CCF, DSPH, and Medical Affairs) to ensure efficient execution of the study management processes.
- Proactively identifying potential operational challenges and in collaboration with senior team members providing resolution plans to ensure study remains on track.
- Implementing and maintaining working processes to promote high quality, efficient, and compliant systems and tools for CO and ISR study management.
- Maintaining a good understanding of industry standards and regulations for CO and ISR studies and keeping abreast of any new changes and developments impacting Late Phase clinical operations.
- Maintaining internal Clinical Operations databases and document repositories.
- Drafting and coordinating reviews of relevant documents, including protocols, informed consents, case report forms, monitoring plans, and clinical study reports.
- Understanding, interpreting, and explaining protocol requirements to others and maintaining study timelines.
- Coordinating reviews of data listings and preparing interim/final clinical study reports.
- Assisting in determining the activities to support a project's priorities within functional area.
- Contributing to the development of RFPs and participating in selection of CROs/vendors.
- Training CROs, vendors, investigators, and study coordinators on study requirements.
- Examining functional issues from an organizational perspective.
- Contributing to the development of abstracts, presentations, and manuscripts.
- Collaborating with local medical affairs colleagues on country specific studies and initiatives.
Skills and Requirements:
- Bachelor's degree and 5+ years of experience within clinical operations.
- Experience within Inflammation or Oncology therapeutic areas is strongly preferred.
- Experience with eTMF, experience with VeevaVault is strongly preferred.
- Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sherron Howard at +1 267 435 8600 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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