Job Opportunities

Recruiter	Central, NJ	Apply
Recruiter wanted to handle clinical and scientific staffing requisitions for major pharmas in the tri-state NY metropolitan region. Areas of expertise include, but are not limited to, medical writers, data managers, clinical research scientists, study managers, drug safety and medical information professionals.

Clinical Study Manager	Northern, NJ	Apply
•The Clinical Study Manager Candidate (CSM) will be a primary interface between Client and the responsible CRO(s) involved in the operations of clinical trials. •The CSM will be responsible for a wide variety of duties including assisting in the preparation of writing study protocols, interacting with Principal and Co-Investigators and other site staff, managing study documentation, i.e., The Trial Master File, and oversight of CRAs in the field. • The CSM must demonstrate leadership and management skills to assure proper operational execution of assigned clinical trial(s); including selection and oversight of CROs/vendors/investigators; development, review, and archiving of project and study specific core documents; preparation of and management of project timelines; and coordination of critical time dependant deliverables. • The CSM may be responsible for managing one or more clinical trials within a specific therapeutic area. • The CSM must demonstrate a working knowledge of FDA regulations, ICH and GCP guidelines to ensure that clinical trials are conducted in compliance with FDA regulations and guidance, ICH and other relevant local and international GCP guidance, and CRO SOPs. In addition, working experience with Electronic Data Capture (EDC) and Interactive Voice Recognition Systems (IVRS) are required. • The CSM will be expected to mentor, supervise, and provide ongoing training to one or more Clinical Research Associates or Clinical Study Assistants. • The CSM will be responsible for maintaining the Trial Master File • The CSM will be responsible for coordinating all aspects of assigned clinical activities including managing CROs, vendors, timelines, and tracking of CRO/Consultant deliverables. • The CSM will Develop and maintain, in conjunction with the Project Leader, detailed project timelines for assigned clinical trials. Identify risks and develop contingency plans to reduce the impact of risks. • The CSM will provide accurate and timely comprehensive written and verbal communications concerning the clinical trial(s), including management updates. • The CSM will be responsible for providing the study management components of protocol budget, including Country Monitoring Agreements, Investigator Grants, Lab Costs, FSP/CRO costs, Clinical Supplies, Investigator Meeting costs • The CSM will assist the Clinical Leader in leading cross-functional team meetings to review clinical trial timelines, objectives, deliverables, quality issues and other day-to-day operations. Ensures internal and external meeting minutes and agendas are generated and disseminated, as appropriate. • The CSM will ensures recruitment plans are in place and are executed in a timely fashion in order to enhance the study enrollment to meet corporate goals. • The CSM will Ensure that monitoring/co-monitoring visit reports and CRO monitoring visit reports are being reviewed and followed. Education: BSc / BA, MS). Biomedical background preferred.¨ Minimum of 5 years experience in Pharmaceutical Clinical Research with an excellent understanding of traditional CRA skills (site identification, monitoring, tracking, data collection and cleaning) and clinical study management.¨ Practical experience of clinical trial methodology (study design)¨ Working knowledge of the therapeutic area and/or study indications is preferred.¨ Knowledge of drug development beyond clinical trials. A N I Professional Staffing

Global Sourcing Manager	Central and Northern, NJ	Apply
This position reports into Head of Global Sourcing Area and works within BHC Procurement across legal entities and national boundaries with a strong focus on procurement strategy and service delivery. This position would provide contract support within a therapeutic or division specialty. This position will also support the identification, selection, and management of suppliers and contracts across the sourcing area. Education: • BA/BS Degree or equivalent experience. Fluent in written and spoken English. A second language will be an advantage. Experience: • At least 3 years experience with progressively increasing responsibility within a major pharmaceutical company or leading Contract Research Organization. The ability to establish strong credibility with both internal and external colleagues and vendors based on previous experience is a pre-requisite. Must possess • A basic understanding of research and development processes, financial management, procurement and purchasing and contract law. • An understanding of the service supplier industry. • Negotiation skills are essential to ensure that all contract negotiations are conducted effectively and with consistency within the BHC procurement guidelines. • Effective communication skills to enable the incumbent to effectively create and maintain alliances with both internal and external colleagues. • Ability to multi-task, time-manage and use initiative. A N I Professional Staffing

Clinical Data Manager	Northern, NJ	Apply
Major Pharma is seeking Clinical Data Managers responsible for providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared clean and locked according to strict performance standards. Review and contribute to the development of trial validation plan related documents and create/approve final CRF design, validation checks and reports necessary to assure high quality and consistent data. Review and contribute to the preparation of protocols, CRFs and prepare or review/contribute to operations manuals. Organize / chair data management meetings. Support and assist clinical data managers, clinical data assistants for allocated trials. Work very closely with Contract Research Organizations (CROs) contracted to perform data management functions. Travel when required. All other duties as assigned. A N I Professional Staffing

CDM Senior Technical Expert	Central, NJ	Apply
Position is responsible for preparing data listings and reports for data clean-up and review using SAS or SQL for execution in I-Review. Provides study level support to the operational groups in the management of individual activities as required. This support includes development of standardized listing, utilities and systems for the clean-up activities performed by CDM. Provides technical support to CDM for SAS related issues. Management of program libraries in UNIX and registration of programs in I-Review. Minimal education required for the job: Bachelors Degree - Any Skills: BS/BA in computer science, mathematics or life sciences. Experience with SAS, SQL. Experience with clinical trial data. Broad knowledge of SAS report writing and SAS macro language. Has a working knowledge of GCDM processes including protocol review, study start up and study support Working knowledge of Clinical Database Development/Reporting tools (e.g. Clintrial, InForm, Data Loading, SAS, SQL, PL-SQL) Validaton automation tools and ad hoc query tools (e.g., I-Review, J-Review) Working knowledge of Cognos reports a plus. Working knowledge of processes associated with the above technologies Demonstrated working knowledge of FDA & ICH Guidelines Working knowledge of drug development and approval process A N I Professional Staffing

Scientific Communications Project Lead	Central, NJ	Apply
Play a key cross functional role as scientific communications specialist team member for important drug development programs. Play a key role in strategic publications planning, assume responsibility for management of scientific publications development, execution, quality, compliance, surveillance and take part in core project team activities. Collaborate with and serve as a resource to both business and research; develop key databases, liaise with internal and external investigators and authors. Supervise writers and external service providers. The right mix of talents is essential. The right candidate should have an advanced degree in a scientific discipline, preferably with scientific or medical education writing background and/or experience in the preparation or planning of scientific communications. Some commercial Pharmaceutical experience is a strong asset. There is potential for some travel. This challenging position requires a take charge, multi-faceted, organized individual that thrives on diversity and has the ability to prioritize, manage and carry out many simultaneous activities in a fast paced team environment. This position, with both hands on and supervisory responsibilities, demands a flexible, adaptable team player with the ability to both lead and take direction, to motivate and to work with a wide variety of personalities. A N I Professional Staffing

SAS Programmer	Central, NJ	Apply
A BA or BS degree in Life Sciences, Computer Science, Statistics, or related field is required with a minimum of 4 years experience in Statistical Programming using the SAS system in clinical data analysis. Or a Masters or equivalent degree with 4 years experience using the SAS system in clinical data analysis is required. Very strong SAS programming skills is required with proficiency in SAS/Base, SAS Stat, and SAS Macros with basic understanding of SAS/Graph. Strong problem solving and analytical skills are desired. Must have clear verbal and written communication and be able to communicate in a timely manner. Position requires excellent collaborative skills and the ability to manage complexity and change. The candidate will have a good working knowledge of CDISC standards. A N I Professional Staffing

Clinical Study Manager	Central, NJ	Apply
Major pharmaceutical player seeks Clinical Study Manager to manage clinical studies and support the processes of supplier selection and management. Will be responsible and accountable for a particular study from availability of Advanced Approved Study Protocol Synopsis until the Database Lock and Trial Master File is archived. Will perform overall management of the study, plan/prepare, and conduct/close-out the study. Will set up study team, track study status, prepare/develop/maintain study plan, plan/order/supply study material, submit study to FDA and IRBs, Monitor sites and select external supplier. BS degree in health sciences and 4 - 5 years experience in clinical research. A N I Professional Staffing

Clinical Research Specialist	Central, NJ	Apply
The incumbent assists with the design and conduct of clinical studies with emphasis on the protocol/TA specific aspects of the protocol. Performs medical monitoring of study data, ensuring appropriate input from clinical research physician and senior clinical research specialist staff. Responsible for the creation, review, and management of SAE case reports. Supports Clinical Sciences and other functional areas in the development of clinical study deliverables. The incumbent will pursue relevant training opportunities and additional project assignments with the goal of assuming increasing autonomy in the execution of responsibilities. Requirements: A bachelor’s degree with major relevant to Clinical Sciences (e.g. biology, chemistry, biochemistry, nursing), or RN (3 yr minimum), and at least three years experience in clinical research or equivalent experience. Direct clinical experience (e.g. nursing) or experience conducting clinical research in the pharmaceutical industry. Excellent oral and written communication skills. Some assignments require / focus on medical writing (e.g. protocol / clinical study report / safety update report). Good computer skills to assist with the clinical data review, and tabulation and summarization of data. Must be able to work effectively with a team. Must be able to multitask Must possess effective time management skills. Must have scientific writing experience. SKILLS Must understand scientific process and have familiarity with medical and statistical concepts. Must have strong analytic skills and ability to make data driven decisions. Desire to work independently and ability to seek guidance as needed. Must have good communication (verbal and written) and computer/database management skills. Experience as a member/contributor to cross functional teams. Qualifications: 4-year (BS/BA) or equivalent ex-US degree from accredited university and 4+ work experience to include a minimum of 2 years experience in drug development and/or health sciences; or advanced degree (e.g. MS) with 3+ years work experience to include a minimum of 1 year experience in drug development.. Prior experience in clinical research a plus. A N I Professional Staffing

Statistician	Central, NJ	Apply
Our client, located in central NJ, seeks a Statistician with at least 2 years experience in the pharmaceutical industry. To write statistical analysis plans, perform statistical analyses (survival analysis in particular) and contribute to and review Clinical Study Report. Oncology background nice. MS with Ph.D. preferred. A N I Professional Staffing

Clinical Research Scientist	Northern, NJ	Apply
- Key pharmaceutical company located in northern NJ seeks a Clinical Research Scientist with Infectious Disease background (nice). Must have a very strong scientific background, and be very comfortable in a clinical research environment. Will initiate study start-up/site selection, meet with investigators and initially devote much of the time in setting up an Advisory Board; will liaise with meeting planning groups and write/review slide decks. At least an MS in Health Sciences, PhD preferred. A N I Professional Staffing

Lead Data Manager	Western, NJ	Apply
- A favored pharmaceutical client located in Western NJ seeks a Lead Data Manager to assist in preparing/updating departmental procedures, training Jr. Assoc in data management procedures/systems, prepare/present data management at Investigator's meetings, including CRF and completion guidelines, coordinate with CRF Designer and ensure study quality of document. Perform SAE reconciliation and discrepancy management, coordinate database development, validation programming and all associated testing with Data Management team. Knowledge of OracleClinical, SAS and MedDRA nice. BS plus at least 3+ years experience in Data Management. A N I Professional Staffing

In-House CRA	Central, NJ	Apply
A key player in the pharmaceutical industry seeks some qualified In-House CRAs to perform the following duties: Review data listings, generate and track queries to closure, reconcile master study file, perform discrepancy resolution management across sites and status reporting, CRF review/pagination/sign-off and provide advance report updates. Will provide status reporting, regulatory document review and milestone maintenance in study management plan, as well as protocol amendment preparation/management. Must have 3 years of direct monitoring experience and familiarity with CRF and database design. Anti-infective background highly desirable. BS degree. A N I Professional Staffing

Drug Safety/Surveillance Specialist	Northern, NJ	Apply
- Major pharmaceutical client located in northern New Jersey seeks Pharmacist or RN with 2 years Drug Safety experience, familiar with medical terminology and MedDRA; Clintrace a plus. To prepare aggregate reports (Annual/Quarterly Periodic ADE Reports and Annual IND Reports); support in preparation of PSURs; maintain documents such as Events of Interest list and the Management Tracker; collaborate with physicians, Operations, Informatics, Quality Training & Compliance & Regulatory Affairs to produce high quality aggregate reports A N I Professional Staffing