Plan and oversee the clinical trials:
- Managing study start-up activities, including understanding ex-US start up requirements, site contracts, essential documents, study tools and planning and training materials
- Select and Manage one or more study vendors (CRO, IWRS, Clinical Supplies), including communication, timelines and budget management
- Assisting with the development of training materials and presenting at investigator meetings
- Building strong relationships with clinical site staff to ensure optimal sponsor-site relationships
- Participating in the identification, qualification and selection of CROs and vendors, including review of master service agreements, budgets and work/change orders
- Interfacing with cross-functional project team
- Ensure compliance with GCP SOP’s and practices in the conduct of the study.
Serve as point of contact for Clinical trials:
- Lead internal and external multi-functional teams and meetings
- Oversee CRO and vendor activities to ensure quality and timely deliverables
- Manage the process of issue escalation/resolution internally and with partners.
- Recognizing potential operational challenges and resolving or escalating, as appropriate
Design trials to meet GCP / local and federal regulations and company quality standards:
- Develop key study documents, protocol, ICF, CRFs and study plans with the VP, Clinical Ops.
- Maintain a strong, detailed knowledge of the protocol and able to address study related questions from CROs/CRAs or study sites
- Performing ongoing clinical data review to ensure data integrity and accuracy
- Performing site-engagement visits and co-monitoring visits
- Minimum of 5 years working in clinical research and/or clinical operations
- At least two or more years of clinical study management experience with global clinical studies
- Previous experience managing CROs, vendors and consultants
- Experience in critical care or in-patient hospital studies is preferred
- Ability to proactively manage protocol execution, including the oversight of CROs, vendors & consultants involved with the clinical program
- Documented training, knowledge & application of current FDA regulations, GCP and ICH guidelines in clinical studies
- Ability to support and experience in managing the development of study plans, including site monitoring, risk mitigation strategies, study budgets and program-level budgets, and clinical supplies management
- Ability to support improvement initiatives (e.g., SOP development, training)
- Strong organizational and time management skills and familiarity with project management principles
Good Clinical Practices (Gcp)
Coherent Remote File System (Crfs)
Based on Job Title, Location and Skills
Apply to this job.
Think you're the perfect candidate?
Help us improve CareerBuilder by providing feedback about this job:
Report this job
Report this Job
Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our
Trust and Site Security Team
privacy and protection,
when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder
Terms and Conditions
for use of our website. To use our website, you must agree with the
Terms and Conditions
and both meet and comply with their provisions.
The Green Key executive recruitment team is uniquely suited to job placement in your industry because we've actually worked in it. We know what the demands are, where the jobs are, and we have exclusive relationships with some of the most sought-after employers around.
With this unique industry insight as its foundation, Green Key has committed itself to honesty, integrity, and to forming the strong, lasting relationships that have become our hallmark.
Founded by a small, dedicated team of finance professionals, Green Key Resources quickly added offices across the country, and now proudly opens doors for candidates and clients across many specialty areas.
Our expertise has expanded, but we'll never outgrow the kind of personal care and dedication a small firm can offer. We built our business around developing and maintaining long-term relationships that serve both candidates and clients, and we bring that enterprising spirit to every single placement.
Our focus lies in the following verticals:
View the full profile
- Accounting and Finance
- Alternative Asset Management
- Financial Services
- Human Resources
- Information Technology
- Legal Support
- Office Support
- Temporary and Contract Recruitment