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Cost Management Incentives is a top-notch recruiting firm specializing in professional staffing across the entire United States for the pharmaceutical and biotechnology industries. We pride ourselves on our personalized approach, and will always provide complete resume confidentiality during all stages of the placement process. Our policy: Cost Management will never submit your resume anywhere without your prior consent.
Job Openings (in alphabetical order):Although we maintain both CONTRACT and PERMANENT openings in the following positions, we receive new job orders for other locations and capacities on a daily basis. Contact us for today’s listings, or email your resume and a member of our team will contact you with jobs that best suit your qualifications!
Associate Clinical Director, Onc / Global:
Assist in the timely and scientifically sound development of the clinical portions of a product
development plan; ensure the quality and timely preparation of all documents submitted for approval
are met by GCP, Clinical Operating Guidelines and Standard Operating Procedures; liaise with appropriate departments to define the timing of
discussion with the FDA and other regulatory bodies on format of clinical NDA and submission issues.
Associate Director, Clinical Research / Clinical Research Manager:
Provide scientific, medical and operational expertise to lead multidisciplinary teams and to design and implement high quality programs on time and within budget.
Clinical Coding Specialist:
Provide timely and professional ongoing management of clinical trial coding data, Phases I to IV,
by preparing coding module for validation plans; manually code medical and therapy terms not
encoded automatically, in a consistent manner across all trials and within projects, with special attention to adverse events; review Adverse Events, Concomitant Medication and Medical History glossaries
in order that databases can be declared clean and locked according to strict quality standards.
Clinical Data Coordinator:
Process clinical trial data in accordance with Client SOPS to ensure integrity;
responsible
for all data management deliverables within clinical studies, including startup activities, database maintenance, and database finalization;
coordinate
activities within a clinical program.
Clinical Operations Manager:
Clinical Research Associate (CRA) – In-house: Primary responsibilities will include, but are not limited to: Coordination and supervision of all aspects of implementing and conducting clinical studies in accordance with Client SOPs, FDA regulations and GCP guidelines; participation in site selection, initiation, monitoring, and close-out activities; assisting with the recruitment of potential investigators; development of clinical study protocols and CRFs; management of all site trial supplies; contribution to the development of protocols and CRFs. Light travel may be necessary.Location: Northeast; Mid-Atlantic; Midwest; West Coast Submit your resume for this position Clinical Research Associate (CRA) – Regional: Monitor assigned clinical sites – from pre-study activities to close-out visits; train study sites in accordance with Federal, State and GCP Regulations; review regulatory documentation and ensure compliance. Evaluate and resolve data queries. Attend Investigator Meetings. Travel varies– contact CMI for specific travel requirements. Location: Nationwide Submit your resume for this position
Clinical Research Document Specialist:
Ensure timely initiation, and as such is responsible to review regulatory documents for accuracy
and completeness; communicate with investigator/study sites on documentum updates/corrections;
ensure receipt of informed consent/IRB approval. Interact with Safety
to manage investigator alerts; assists with input and management of the investigator databases.
Location: Northeast Submit your resume for this position
Contracts Manager: Manage all activities associated with the development and execution of contracts for CROs, sites and other external vendors;
evaluate ongoing performance of CROs/external vendors with respect to quality of work, accuracy, cost, and other related parameters;
liaise with Legal Department to resolve individual contract issues.
Data Manager: Handle data gathered during clinical trials;
perform data validation; Reconcile SAEs; assist with review and evaluation of
protocol against CRFs; ensure protocols and SOPs are met from study start up to database lock.
Director Clinical Research / MD:
Function as a Clinical Indication Leader; review incoming data related to studies and have oversight
of clinical study protocols; work directly with and report to the Clinical Program Leader in overseeing project safety and in designing and
implementing protocols to provide patient access to novel molecular entities prior to registration.
Documentation Specialist:
Assist in the management of records related to ongoing Phase I, II, and III clinical programs to assure
that all documentation is in compliance with current regulations, GCP/ICH and SOP requirements.
Project Manager: Responsible for day-to-day management and mentoring of clinical study team;
track study
progress with respect to quality and speed; ensure clinical studies are conducted in accordance with State and Federal Regulations and ICH/GCP Guidelines, and Client SOPs;
assist with personnel and budgetary requirements.
Regulatory Affairs: - Associate, Manager and Director levels:
Serve as a Regulatory Affairs representative by implementing plans
to facilitate the drug development progress in Phase I through Phase
IV trials; prepare and make FDA submissions; serve as the regulatory
liaison with the FDA and other regulatory agencies for assigned projects; communicate changes in FDA requirements to team members.
Safety Associate: Intake, follow-up, and data entry of adverse event
information, from all sources, into the safety database in accordance with Client SOPs and FDA/ICH Regulations/Guidelines.
Study Manager: Serve as clinical trial leader. Manage the execution of clinical studies in accordance with protocol, GCP standards, FDA Regulations and Client SOPs;
responsible
for research site identification and training, investigator meeting planning, case report form and data clarification form management with sites, and management of SAE reporting;
identify study progress in
regard to timeline goals and conduct plans. |