Clinical Affairs Manager

* Acts with a high degree of independence to guide or supervise the process of clinical trial planning, execution, and close-out.
* Responsible for the preparation of study protocols, informed consent forms, IRB submissions, case report forms, monitoring tools, analysis plans, clinical study reports and other study-related documents in accordance with established processes and procedures.
* Leads the selection and management of CROs and vendors, and is responsible for ensuring adherence to study scope, budget, and timelines.
* Maintain contact and work effectively with investigators, coordinators and other site staff.
* Monitor and manage project budgets and timelines across assigned studies.
* Prepare clinical monitoring plans and conduct monitoring performance assessments as needed.
* Provide guidance and direction to in-house/contract CRAs in the field. Maintain assurance of regulatory compliance of investigational sites with GCPs, ICH guidelines, and company SOPs.
* May conduct prestudy, initiation, interim monitoring, and closeout visits and perform drug accountability as needed.
* Prepare and track required regulatory documentation from clinical sites.
* Review and resolve discrepancies in clinical data with clinical sites and/or CRO staff.
* May present at investigator meetings.
* Represent Clinical Affairs on project teams.
* Maintain regular internal contact with relevant departments such as clinical supplies, regulatory affairs, QA, non-clinical, drug safety and others as necessary.
* Assist in the hiring, training and leading of Clinical Affairs staff, and provide technical leadership.
* Contribute toward the creation, development, and implementation of new or revised processes, SOPs, training, etc., as needed.

Redquirements: Bachelors degree preferably in a scientific discipline or health-related field, plus 6 or more years of clinical research experience (including at least 4 years in the pharmaceutical industry). Experience in Phases I-III of drug development and in executing multiple trials in parallel. Must have demonstrated problem-solving abilities in managing CROs, vendors and clinical sites, and demonstrate tactfulness and diplomacy in dealing with study coordinators and physicians. Ability to develop and administer budgets, timelines, and trial-specific performance metrics are required.

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