Clinical Operations Manager
Proclinical is currently recruiting for a Clinical Operations Manager for a biopharmaceutical company located in New York, NY. Successful candidate will be responsible for operational aspects of Phase II-III clinical trials oversight including the delivery of every study on time within budget and scope in compliance with GCP's, SOPs.
- Produce, manage and trial documentation and ensure proper retention and archiving
- Support the dashboards and tracking systems to determine trial progression.
- Organize and lead study specific meetings.
- Collaborate with the Clinical Supplies Vendor to validate Investigational Medicine Products (IMP) needs, specifications, packaging, shipment (including resupply) and reconciliation process.
- Participate in bid defense process, selection and management of vendors, development/follow-up of the associated budget.
- Preparation and oversight of study audits/inspections both internal and external.
- Lead User Acceptance Testing.
- Coordinate International Trials and lead the global study team. Knowledge of international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems, processes and SOPs).
Skills and Requirements:
- MA/MS, PhD or PharmaD in scientific discipline or equivalent RN preferred.
- 7+ years of experience in biotech/pharmaceutical environment.
- Capability to challenge decisions/status-quo/requests using risk management approach (e.g. unrealistic timelines, unplanned database snapshot).
- Ability to work cross-functionally fostering team spirit and team motivation (e.g. study team or transversal project team).
- Demonstrate stakeholder management skills (e.g. ability to manage expectations).
- Strong organizational skills including attention to detail and multi-tasking skills.
- Strong written and verbal communication skills.
- Demonstrated ability to adapt and be flexible to change, managing internal and external challenges & opportunities
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 call Natasha Patel (+1) 617-778-7319 or upload your resume 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.
Proclinical Staffing is an equal opportunity employer.