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Clients First Staffing is a nationwide staffing firm specializing in the placement of all levels of Pharmaceutical, Clinical, and Emerging Technology professionals on both a full-time and contract basis. Our mission is to provide professional, knowledgeable and skilled staffing resources to all of our customers.
With over 20 years combined experience, we pride ourselves on only sending the most qualified professionals that meet the specific need of our clients. We perform extensive phone interviews, reference checks and degree verifications on all of our candidates. We treat each client and candidate with the utmost respect and professionalism. No candidates will ever be submitted without the permission of the candidate. We are committed to maintaining a high standard of quality customer service by employing only the very best personnel in the field.
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Clients First Staffing is committed to continually strive for excellence in serving the Pharmaceutical, Clinical and Technology services community through partnerships with both clients and employees who have committed to the same level of excellence to which our organization aspires.
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We specialize in providing the following professional staff: |
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• IT Professionals
• CRAs
• SAS Programmers
• Medical Writers
• Data Managers
• Data Coordinators
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• Field Engineers
• Safety Associates
• Bio Statisticians
• Regulatory Affairs Specialists
• Clinical Project Managers
• Director of Clinical Research
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Apply To:
resume@clientsfirststaffing
| Field Service Engineer - Positions needed Nationwide |
Major Medical Devices company seeks Field Service Engineers for positions in Worcester, MA and New York, NY.
Job Description : The incumbent will be responsible for Repairing, calibrating, and testing of BIOMEDICAL and SCIENTIFIC equipment at Client sites. Assisting in lab experiments with bio medical staff.
Desired Equipment knowledge: advanced cryo refrigeration units, histology equipment, skin graph staining equipment, cryostats, billirubinometers, ophthalmology equipment and a wide range of microscopes. Performed medical equipment certifications.
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| Manager, Government Contracting |
Pharmaceutical Leader in Northern NJ seeks a Manager, Government Contracting
Job Description : This position is responsible for assuring compliance with all Federal Programs pricing, reporting, and data requirements. This position will propose policy changes, which assure continued compliance with Federal Program regulations and with all Federal Programs and contracts. Analyze the impact of program amendments, as well as interpret implications on Federal Programs of various commercial contracting decisions. Review all government calculations prior to submission, challenge validity of data, and effect invoice adjustments as appropriate.(i.e.; ASP, AMP, URA, Best Price, NFAMP, Federal Ceiling Price, Federal Supply Schedule price, Industrial Funding Fee payments, Public Health Service Pricing, etc.) Will act as the point person for communications with government contracting officers at VA/DoD and CMS. Responsible for the review and approval of contracting proposals with appropriate government agencies (i.e.: Federal Supply Schedule, Blanket Purchase Agreements, State Supplemental programs, etc.). Oversee the rebate processing for the Medical Drug Rebate Program. Oversee the accurate implementation of government contract membership and pricing.
Job Qualifications : •BS/BA in Finance or Pre- law.
•5 years experience in pharmaceutical contracting including specific experience in Federal Programs contracting.
•Knowledge of industry contracting processes and general knowledge of government pricing, claims, membership and discount processes required.
•General business law knowledge required.
•Good Analytical skills.
•Ability to work and complete task within prescribed timelines and due dates.
•Extensive knowledge of Veterans Healthcare Act (VHCA)-Sections 602, 603, and associated master Agreements.
•Familiar with the Deficit Reduction Act.
•Knowledge of the relevant agreements/contracts (FSS, DAPA, CMS).
•Review of amendments, statutes, interpretations of VHCA is required.
•Excellent verbal and written communication skills.
•Experience with the Medicaid Drug Rebate Program.
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| Sr. Manager, Compliance, Sales and Marketing |
For our client, a pharmaceutical leader in Northern NJ, we seek a Senior Manager, Compliance, Sales and Marketing.
Job Description :
The Senior Compliance Manager, Sales and Marketing, will work with the Director of Compliance, Commercial Operations, to oversee the implementation and effective operation of the compliance program for the sales, marketing and commercial functions at Company. Responsibilities include providing overall assistance to ensure that sales, marketing and commercial activities are compliant with ethical and legal obligations by assisting with the implementation of compliance policies and procedures, ensuring that we have addressed appropriate risk areas, providing daily guidance to sales and marketing personnel, developing and delivering appropriate training, conducting routine monitoring, coordinating and conducting investigations to ensure that complaints and concerns are adequately investigated and addressed, and assisting with department and enterprise-wide compliance projects and initiatives.
Major Activity:
•Conduct routine monitoring of sales, marketing and commercial activities.
•Provide daily guidance and field inquires from the sales and marketing personnel about policies, procedures, compliance risks, etc.
•Develop and provide training regarding compliance, ethical and other issues.
•Handle and/or oversee investigations arising from employee complaints.
•Provide assistance with department and enterprise-wide compliance projects and key initiatives.
Job Qualifications : •Must Know: Knowledge of laws, regulations, industry guidance and best practices regarding compliant sales and marketing activities, primarily through experience in pharmaceutical industry and/or with pharmaceutical manufacturer activities.
•Experience: 5-10 years broad experience in pharmaceutical industry and/or with pharmaceutical manufacturer activities. Must possess strong verbal, written, presentation, and other communication skills.
•BS/BA degree required, advanced degree preferred (MS, MBA or JD)
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| Clinical Data Manager |
| Clinical Data Manager – Major Pharma Corporation located in Northern NJ seeks experienced Data Managers who understand and has been involved in the entire Data Management process. Responsibilities include identifying errors/inconsistencies and resolve them or initiate their resolution to endure high quality and timely database locks. Understand the data management requirements of the protocol in order to perform Data Management tasks. Identify/review standard CRFs and CRF Completion Guidelines (CCGs), electronic or paper. Freeze and lock data as appropriate in a timely manner for statistical review, blinded interim quality review and final DB lock. Perform SAE reconciliation, writing of Data Management plans, generate/track and update queries. Perform quality control and archiving processes, as well as data entry of paper trial data. BS degree. |
| Director, Biostatics, Translational Medicine |
Northern NJ Pharma client needs Director, Biostatics, Translational Medicine -
Description: This position will be responsible for leading the statistical strategy in support of early clinical development goals. This will include the defining of the PK profile, establishment of maximum tolerated dose, confirmation of pharmacological activity in man, selection of therapeutic dose, and early demonstration of clinical effectiveness (proof of concept). The qualified candidate will have the technical expertise and demonstrated capability to lead statistical teams within the pharmaceutic! al industry, and have an established reputation within the pharmaceutical Biostatistics field.
Job Qualifications : Masters degree or Ph.D in Biostatistics or related discipline
At least 10 years relevant experience in the pharmaceutical industry, including project or line management experience
Experience within AI, GI, CNS, or Oncology preferred
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| Clinical Trial Leader |
Large Pharma client in Northern NJ seeks a Clinical Trial Leader II (Contract position.
Job Description :
DUTIES >> Responsible for the planning and implementation of all operational aspects of assigned Translational Medicine studies (e.g. medium to high complexity studies; first in man, patient studies, multi-center studies, mechanistic studies) from synopsis to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).
SKILLS >> 1. Accountable for the writing of clinical protocols and related documents in collabora-tion with the Clinical trial Team (CTT): lead the clinical trial protocol development process; contribute to the operational and scientific input given for the development of trial-related documents and processes which reside in other line functions.
2. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliver-ables are met according to timelines, budget, quality standards and operational pro-cedures: chair CTT meetings (as needed), report study progress and issues to CTT and TM-SO Management; lead trial level interactions with internal line functions and external CROs e.g. those providing monitoring and site management services.
3. Function as a Lead CTL on studies for Full Development and assist in the coordina-tion of TM related submission documents.
4. Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs
5. In collaboration with CRO management, CTT and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Initiation meet-ing
6. Support the CRA on study related questions and serve as point of contact for manag-ing/answering questions relating to trial procedures and subjects eligibility
7. Responsible for set up and maintenance of the Trial Master File for assigned studies.
8. Regularly update all trial information databases in order to manage accuracy of in-formation
9. Approve for all necessary center payments as per financial agreements.
10. In collaboration with the TME and CTT, lead the ongoing review of the clinical trial medical/scientific data (as needed), analysis and interpretation including the devel-opment of first interpretable results, clinical trial reports, publications and inter-nal/external presentations.
11. Co-ordinate pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved.
12. Contribute to identification and evaluation of new centers suitable for performing TM studies in healthy volunteer and patients.
13. Responsible for implementation of best practices and standards for trial manage-ment within TM, including sharing lessons learned.
14. Provide TM-SO expertise to other departments and line functions e.g. Drug Supply Management (DSM), through e.g. cross-functional working groups or TM Initiatives.
15. Contribute to talent and career development of TM staff through active participation in on-boarding, training and mentoring activities.
EDUCATION >> BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD.
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