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| Director, Clinical Affairs - Job # 1939 |
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Client Synopsis:
Full Scale Solutions is currently recruiting for the following position located in Bethlehem PA. Relocation will be provided.
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Essential Duties and Responsibilities:
We are currently seeking a Director of Clinical Affair who will be responsible for managing the overall day-to-day Clinical Affairs staff, monitoring and IDE project performance. Ensure compliance to EU/FDA regulations for clinical studies and execution of IDE protocols as written. Will Manage the Clinical Affairs Manager(s) and Clinical Research Associate(s) and report to the SVP, RA/QA.
Duties include:
- Manage the strategic planning and execution of Clinical Studies within the daily operations.
- Facilitate the generation and/or review and approval of clinical study protocols and required SOPs.
- Provide input for the design, review and approval of case report forms (CRFs).
- Provide training and guidance to ensure that Company staff are trained to execute and follow the clinical study protocols and understand the consequences of out-of-protocol events and errors.
- Provide training and guidance to ensure that staff is trained to review CRFs records for accuracy, completeness and compliance to requirements.
- Provide technical assistance to staff, operations, and donor centers, as required.
- Evaluate new tests and methodologies.
- Organize and maintain Clinical Study files, in order to meet customer, regulatory, and product management requirements.
- Participate in overall management review and planning of IDE study operations to enhance compliance with protocols and efficient/cost effective execution of studies.
- Interface with the Independent Review Board (IRB) and act as liaison between that group and the company.
- Initiate and participate in clinical affairs and technical staff hiring decisions, goal setting, performance monitoring and review, and disciplinary action as appropriate.
- Collaborate with the SVP of RA/QA in the preparation and monitoring of department budgets.
- Facilitate customer and contract research organization (CRO) monitoring visits, audits, investigator's meetings and business planning functions.
- Participate in regulatory inspection process and work with other company management to provide prompt response to regulatory agency or internal audit findings.
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Experience
- Master's or PhD. Level with ten (10) years experience.
- Minimum three (3) years supervisory experience.
- Strong written and verbal communication skills.
- Experience with biologics and drug clinical studies is required.
- Experience with source plasma and laboratory methods used in blood/plasma screening for bloodborne pathogens is a strong preference.
- Ability to travel 10% to 20% during the work year.
- Ability to organize, work independently and adapt to changing priorities.
- Ability to handle multiple tasks - flexibility.
- Willingness to take and give direction.
- Willingness to work diverse shifts and overtime, as required.
- Familiarity with working in a regulated environment. (CLIA, GMP, GCP, QSR, ISO, EU Harmonized Standards or other)
- Understanding of budget preparation, goal setting and performance monitoring processes.
- Ability to operate computer keyboard and calculator.
- Ability to travel by plane, automobile, train and other methods of public transportation.
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 For confidential consideration please submit a resume and salary history to
claire@fullscalesolutions.com.
Full Scale Solutions is an Equal Opportunity Employer.
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