For a leading client, I'm looking for a Global Clinical Operations Manager to strengthen the Global Clinical Operations team.
- Responsible for development and implementation of study protocol(s) in accordance with Good Clinical Practices (GCPs) and current Standard Operating Procedures (SOP(s)).
- Manages global clinical operations activities for assigned projects, including but not limited to, the following:
o Prepares/procures of all manner of documents and supplies related to the clinical trial process (e.g. Investigator’s Brochure, Protocols, Case Report Forms, Informed Consent Documents, etc.)
o Manages Clinical Operations activities to evaluate and select sites, vendors (e.g. central laboratories, reading centers), consultants, CROs, etc. for assigned studies.
o Develops monitoring requirements to assure quality monitoring activities.
o Negotiates and prepares all legal and financial documents (e.g. contracts, budget proposals, confidentiality and indemnification agreements, insurance, etc.).
o Monitors clinical studies to assure they are conducted in compliance with the protocol, Standard Operating Procedures, Good Clinical Practice and appropriate regulatory requirements.
o Performs data cleaning activities throughout the study and in preparation for Database Locks.
- Participates in strategic discussions regarding the design of global clinical programs and in reporting the progress of clinical programs by working collaboratively with the global sub-teams.
- Represents Global Clinical Operations on project teams for assigned projects as requested.
- Prepares and/or presents written and oral presentations regarding clinical trial progress/results.
- Maintains up to date extensive knowledge and understanding of Good Clinical Practices, regulations and guidance documents and industry trends/best practices.
- Develops and maintains close working contacts with other functional areas outside of Global Clinical Development and Operations (GCDO) e.g. Medical Affairs, Regulatory, Pharmaceutical Development, Business Development and Strategic Marketing, Finance, etc. to facilitate clinical trials research.
- Develops and maintains relationships with key opinion leaders (KOLs) and clinical scientists to support company development activities on a global basis.
- If requested, creates or modifies SOPs/Work Instructions (WIs) and submits them to the Global Clinical SOP Steering Committee, gets agreement with all reviewers on the SOPs/WIs final draft and escalates to the Global Clinical SOP Steering Committee when the agreement cannot be obtained.
- BSc degree in a scientific discipline, RN, BSN degree or equivalent; MS, PharmD and/or PhD preferred.
- English business proficiency.
- Five or more (5+) years of clinical research experience, preferably in ophthalmology.
- Significant experience in the oversight of day-to-day clinical operational aspects of drug development.
- Prior supervisory experience of operations personnel (e.g. CRAs, consultants, etc.) and vendor management.
- Strong verbal communication and scientific writing skills, and good interpersonal/group skills.
- Must be able to communicate information between regions and with senior level management both inside and outside of the company.
- Significant knowledge of EMA, FDA and ICH regulatory requirements e.g. Guidances, guidelines, Code of Federal Regulations, etc. and implementation guidelines.
- High level of understanding of scientific and statistical principals regarding clinical trial design and analysis/presentation/reporting of data collected in clinical trials.
- High degree of computer proficiency, preferably in MS Office environment.
- Highly detail oriented.
- Adaptable to changing regulatory environments.
- Flexible team player with the ability to work in a changing environment.
- Demonstrated track record of driving projects/deliverables to completion within established deadlines.
- With minimal input from management, must be able to set and prioritize goals and objectives; excellent time management and organizational skills.
- Proven ability to manage teams.
- Must demonstrate tact and the ability to positively influence others across all organizational levels.
- Ability to work collaboratively and effectively with people from different cultures, previous work experience with Japanese companies a plus.
If you are interested in the above description, apply with your CV PS: Did you also know that we offer an attractive referral scheme? For more information please contact Selin Ozbeden on +31 (0)20 20 44 502