Clinical Project Manager
Proclinical is currently seeking a Clinical Project Manager for a clinical-stage biotechnology company located in Newark, NJ. Successful candidate will be responsible for the planning and executing of trials for the Clinical Operations function.
- Ensure that global clinical strategies are translated to study specific strategies.
- Ensure that the trials are run in adherence to all relevant regulations including GCP, ICH, local regulatory requirements, as well as SOPs and policies.
- Provide operational input into study designs, protocols and study plans to ensure that they are operationally feasible at the country, site, and patient levels.
- Oversees the execution and adherence to all integrated study operation plans, with inputs from key stakeholders.
- Oversee the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with CRO Management and key stake holders.
- Set Key Performance Indicators (KPIs) and roll out metrics to track the quality and performance of the studies.
- Monitor study progress, study budget, study timeline.
- Identify quality and deliverable risks, roll mitigation plans together with the relevant stakeholders, to ensure risks are minimized.
- Establish good working relationships with the participating sites and be the point of sponsor contact escalated site issues.
- Conduct regular onsite monitor assessment visits.
- Provide inputs into responses for site audit report and Inspection report as well as be responsible for oversight of associated plans.
Skills and Requirements:
- Bachelor's in a field of Biomedical science, pharmacy, nursing, or medical related courses.
- 10+ years' experience working in clinical research and at least 4 years of clinical project management experience in oncology studies.
- In depth knowledge of oncology trials requirements, clinical research principles such as ICH GCP as well as regulatory requirements.
- Strong communication and influencing skills.
- Strong organizational and problem-solving skills.
- Strong supervision and oversight skills.
- Effective presentation skills.
- Strong ability to deliver results to the appropriate quality and timeline metrics.
- Good judgment.
- Ability to manage competing priorities.
- Experiences in immuno-oncology and/or gene and cell therapy studies are advantages.
- Proficiency in MS Excel required, programming knowledge an advantage.
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 Susan Chapman at (+1) 646-542-0158 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.