Full Time Positions
Sr. Principal Biostatistician Northern NJ Apply
Sr. Principal Biostatistician - Top Tier Pharma, located in Northern NJ, wishes to hire an MS in Statistics with 6 yrs experience or a PhD with 2 years of background in all tasks of a Trial Statistician and proven knowledge in Statistics and its application to clinical trials. Will be responsible for all statistical tasks of individual clinical trials. May serve as a Project-Level Program Statistician. Will perform clinical trial design and planning, write analysis plans, monitor reporting activities including exploratory analyses to support publications. May be assigned to lead small projects with increasing autonomy and accountability. Track clinical trial/allocated project activities and milestones and ensure timeliness and quality of all deliverables. Adhere to SOPs, Master Analysis Plans, GCP & regulatory guidelines.

Manager, Medical Writing Central NJ Apply
Manager, Medical Writing – Provider of exceptional clinical research service, located in central NJ, is looking for leader with an advanced degree in Life Sciences and 3 – 5 years in a supervisory capacity in a pharmaceutical, CRO or biotech medical writing position. Strong background in ICH document format/content and FDA guidelines, with ability to interpret statistical and clinical data. Will be responsible for the management of projects and contract writers, as well as writing/editing clinical documents in support of global regulatory applications. Independently prepare CSRs, Protocols, Overviews and other regulatory supporting documents on investigational drugs in various stages of clinical development. Manage allocation of tasks to Writers and coordinate other tasks among Writers, Biostatisticians, SAS Programmers, Publishers etc. Review work of Writers for accuracy, quality and focus on adherence to appropriate format and stylistic requirements. Solid experience with assembling proposals, budgets, estimates of timelines for client face-time. Ability to stay on top of lots of projects – multitask. Great attention to detail.

Consulting Positions

Drug Safety Specialist, Global Drug Safety Central NJ Apply
Drug Safety Specialist, Global Drug Safety – Leader in the pharmaceutical industry, located in central NJ, seeks an RN (Critical Care, Oncology, MedSurg preferred) or Rph/PharmD with at least two years of relevant clinical or drug safety experience. To manage safety data within the central safety database covering both pre and post-market activities, and to ensure that individual Adverse Event Case Reports are evaluated, investigated and accurately computerized. Execute receipt of Drug Safety phone calls and complete telephone AE form; create phone call communication logs in ARISg. Execute QC on key fields of serious cases; create key fields updates in ARISg based on QC as needed; execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality); develop event rankings; create dechallenge/rechallenge determinations; develop follow-up needs for AE reports; create or review/update generated follow-up letters as appropriate. Support the identification of corrections and creation of updates in ARISg following medical review. Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates.

Senior Clinical Study Manager –CNS Chicago, IL Apply
Senior Clinical Study Manager –CNS: Major presence in clinical research, located in the Chicago area, seeks a Professional with an MS or PhD in Health Sciences w. at least 2 years of clinical trial experience (2 with a Sponsor), and 1 years background managing global clinical trials in Phases 2 and 3. Must have strong knowledge of protocol and clinical drug developments processes, clinical study design, study planning/management and monitoring. Must have managed a CRO and have global trial experience. Background writing study protocols, ICFs and study plans required. Will plan, initiate and execute clinical studies, be accountable for effective management of budgets (up to 100M), timelines and resources for assigned trials and be responsible for effective training/management of interactions with study team, study sites and vendors for assigned studies. Manage and lead the day to day operations of assigned studies to ensure completion in compliance with GCP/ICH guidelines and other regulatory requirements. Provide accurate and up-to-date study information and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management. Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables. Lead feasibility assessment/selection of countries/sites for study conduct and oversee the clinical aspects of timely data cleaning, data analysis and participate in data reviews and review of statistical analysis plans. Proven project management skills. Up to 25% travel when needed.

Senior Clinical Study Manager –Urology Chicago, IL Apply
Senior Clinical Study Manager –Urology: Major presence in clinical research, located in the Chicago area, seeks a Professional with an MS or PhD in Health Sciences w. at least 3 years of clinical trial experience (2 with a Sponsor), and 2 years background managing global clinical trials in Phases 2 and 3. Must have strong knowledge of protocol and clinical drug developments processes, clinical study design, study planning/management and monitoring. Must have managed a CRO and have global trial experience. Background writing study protocols, ICFs and study plans required. Will plan, initiate and execute clinical studies, be accountable for effective management of budgets (up to 100M), timelines and resources for assigned trials and be responsible for effective training/management of interactions with study team, study sites and vendors for assigned studies. Manage and lead the day to day operations of assigned studies to ensure completion in compliance with GCP/ICH guidelines and other regulatory requirements. Provide accurate and up-to-date study information and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management. Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables. Lead feasibility assessment/selection of countries/sites for study conduct and oversee the clinical aspects of timely data cleaning, data analysis and participate in data reviews and review of statistical analysis plans. Proven project management skills. Up to 25% travel when needed.

Senior Clinical Study Manager –Transplant (Solid Organ) Chicago, IL Apply
Senior Clinical Study Manager –Transplant (Solid Organ): Major presence in clinical research, located in the Chicago area, seeks a Professional with an MS or PhD in Health Sciences w. at least 3 years of clinical trial experience (2 with a Sponsor), and 2 years background managing global clinical trials in Phases 2 and 3. Must have strong knowledge of protocol and clinical drug developments processes, clinical study design, study planning/management and monitoring. Must have managed a CRO and have global trial experience. Background writing study protocols, ICFs and study plans required. Will plan, initiate and execute clinical studies, be accountable for effective management of budgets (up to 100M), timelines and resources for assigned trials and be responsible for effective training/management of interactions with study team, study sites and vendors for assigned studies. Manage and lead the day to day operations of assigned studies to ensure completion in compliance with GCP/ICH guidelines and other regulatory requirements. Provide accurate and up-to-date study information and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management. Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables. Lead feasibility assessment/selection of countries/sites for study conduct and oversee the clinical aspects of timely data cleaning, data analysis and participate in data reviews and review of statistical analysis plans. Proven project management skills. Up to 25% travel when needed.

Sr. CRA with Heavy Oncology USA Apply
Sr. CRA with Heavy Oncology - Growing Midwest Pharma, located in the Chicago area, seeks a degreed individual in Health Sciences or nursing w. 5+ years solid tumor experience, 4 yrs exp. in the pharma/CRO space and 8 years monitoring background. Basic knowledge of drug development and clinical study execution including GCP regulations (FDA 21CFR, EU Clinical Trials Directive, ICH) and ability to integrate/apply GCP, clinical operations and scientific knowledge during the preparation, monitoring and subsequent data review for studies. Reporting to Director of Clinical Operations and Clinical Study Manager, will support/drive activities required for study start-up, management and close-out of studies. Responsible for study site recruitment, qualification, initiation, routine monitoring and close-out visits, as well as site correspondence, monitoring reports and follow-up letters. Will perform contract CRA oversight, study site recruitment study clean up, monitoring, SAE reconciliation. Accountable for study metrics, enrollment monitoring, study and project level budgets/contracts and generation of reports/data for clinical staff meetings/executive meetings and QA audit responses. Responsible for protocol, amendment and CRF development and review, database and data cleanup/review. Must show documentation of most recent GCP Training.

Senior Clinical Study Manager – Oncology Chicago Apply
Senior Clinical Study Manager – Oncology: Major presence in clinical research, located in the Chicago area, seeks a Professional with an MS or PhD in Health Sciences w. at least 5 years of clinical trial experience, and 2-4 years background in managing Oncology clinical trials in Phases 1 and 4. Must have strong knowledge of protocol and clinical drug developments processes, clinical study design, study planning/management and monitoring. Must have managed a CRO and have global trial experience. Will plan, initiate and execute clinical studies, be accountable for effective management of budgets, timelines and resources for assigned trials and be responsible for effective training/management of interactions with study team, study sites and vendors for assigned studies. Manage and lead the day to day operations of assigned studies to ensure completion in compliance with GCP/ICH guidelines and other regulatory requirements. Provide accurate and up-to-date study information and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management. Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables. Lead feasibility assessment/selection of countries/sites for study conduct and oversee the clinical aspects of timely data cleaning, data analysis and participate in data reviews and review of statistical analysis plans. Responsible for study budgets up to $100M. 25% travel required.

Instructional Designer with Wavepad Software North Central NJ Apply
Instructional Designer with Wavepad Software – Innovative, leader in clinical research, located in central NJ, seeks a BS/BA with 3-5 yrs. in Instructional Design (related exp) working with training systems. Solid understanding/application of adult learning principles and training methods and thorough knowledge/expertise with e-learning tools/software. Ability to storyboard/create a lesson plan and experience leading projects. Captivate, Articulate required, as is background in recordings/voiceovers using Wavepad SW. Will provide instructional design/development expertise to the Training Organization, providing instructional materials and training delivery methods through the use of best practices methodology (ADDIE – a must). Develop and conduct training assessments to determine the learner’s comprehension/competency of the subject matter. Plan and participate in training program pilots to assure the effectiveness and quality of the training program’s design/delivery and deploy finalized training. Lead the collaboration on content, design and delivery with SMEs, Technical Trainers, Managers, etc to produce instructional materials in compliance with learning needs. Develop instructor guides/participant manuals and develop/permorm evaluation of the program design. Excellent interpersonal, facilitation, presentation and communication skills. Must hit the ground running.

Clinical Data Manager, II Northern NJ Apply
Clinical Data Manager, II – Pharmaceutical Leader, located in Northern NJ, seeks a very high functioning person, with BS degree and the ability to work independently as well as complete a high volume of work. SAE and 3rd party reconciliation exp. helpful. Provide ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensure their resolutions in order that database can be declared clean/locked. Provide ongoing database status reports, proactively identifying issues for timely resolution in order to support continuous data cleaning and on-time quality database lock. Review/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/consistent data. Review/contribute to the preparation of protocols, CRFs and prepare or review/contribute to operations manuals.