YOU MUST BE WILLING TO BE OFFICE-BASED IN THE PRINCETON AREA FOR THIS POSITION. This is an opportunity to work in study start-up for clinical trials on behalf of one of the leading pharmaceutical companies in the world. Job Description: • Independently manages multiple country, study and site level deliverables during start-up and maintenance both within the company and external business partners and vendors, when required. • Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones...

YOU MUST BE WILLING TO BE OFFICE-BASED IN THE PRINCETON AREA FOR THIS POSITION. This is an opportunity to work in study start-up for clinical trials on behalf of one of the leading pharmaceutical companies in the world. Job Description: • Independently manages multiple country, study and site level deliverables during start-up and maintenance both within the company and external business partners and vendors, when required. • Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones...

This is an opportunity to monitor clinical trials on behalf of one of the leading pharmaceutical companies in the world. Job Description: • Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits in collaboration with Site Managers and/or Clinical Trial Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigato...

DESCRIPTION Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grants and contracts Principal Responsibilities: • Responsible for drafting, negotiating, and finalizing clinical ...

DESCRIPTION Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials. Assists in and/or directs the development of scope of work and analysis of terms and conditions. Provides specialized support to trial managers and clinical group in the pricing, planning, execution and control of grants and contracts Principal Responsibilities: • Responsible for drafting, negotiating, and finalizing clinical ...

This is an opportunity for you to do pricing and budgets for clinical trials for one pharmaceutical sponsor. JOB DESCRIPTION: • Responsible for the development and analysis of clinical site reimbursement for Phase 0-4 protocols across all therapeutic areas. Provide support to the clinical team in the development and analysis of global per patient and site budgets to ensure consistency in development and adherence to healthcare compliance, legal, organizational and other applicable guidelines. • Responsible for the development of fair market va...

This is an opportunity for you to do pricing and budgets for clinical trials for one pharmaceutical sponsor. JOB DESCRIPTION: • Responsible for the development and analysis of clinical site reimbursement for Phase 0-4 protocols across all therapeutic areas. Provide support to the clinical team in the development and analysis of global per patient and site budgets to ensure consistency in development and adherence to healthcare compliance, legal, organizational and other applicable guidelines. • Responsible for the development of fair market va...

PLEASE DO NOT APPLY FOR THIS POSITION IF YOU ARE NOT LOCATED IN THE SF BAY AREA. We have a very well established pharmaceutical client located by SFO airport and looking for people to work in Pharmacovigilance/Drug Safety in drug safety intake. Primary Responsibilities: • Inbox Management and Case Receipt • Case Registration and Confirmation • Case Follow-Up Inbox Management and Case Receipt The Service Provider will be required to monitor the company Inbox for case intake, and ensure all emails are triaged and actioned appropriate...

PLEASE DO NOT APPLY FOR THIS POSITION IF YOU ARE NOT LOCATED IN THE SF BAY AREA. We have a very well established pharmaceutical client located by SFO airport and looking for people to work in Pharmacovigilance/Drug Safety in drug safety intake. Primary Responsibilities: • Inbox Management and Case Receipt • Case Registration and Confirmation • Case Follow-Up Inbox Management and Case Receipt The Service Provider will be required to monitor the company Inbox for case intake, and ensure all emails are triaged and actioned appropriate...

Responsibilities: In collaboration with Project Director, defines, develops and sets project timelines, budget, necessary procedures, staffing requirements and resources in various phases of projects. Directs and coordinates the staff and activities to ensure goals and objectives are accomplished within projected time-frames and budget requirements. Reviews status reports and modifies project schedules and/or plans as required. Prepares and presents project reports for management, clients, or others. Conducts clinical protocol training and Stan...

The Proposal Manager will assist the Business Development team in the preparation of proposal response documents associated with new business opportunities and will work closely with the Clinical SMEs, to prepare customized, comprehensive responses and budgets. Responsibilities: • Coordinate activities of proposal team members in preparing responses to Request for Proposals and Request for Information documents • Facilitate the preparation of proposal budgets. • Work closely with senior management, business development, project, and technical ...

Multiple perm. positions available! Remote! No sponsorship available! Sr. Principal Biostatistician • Must have MS or PhD in Statistics. No other degrees acceptable. Minimum 10+ years exp. Minimum of 1 year of CRO experience as a Project Lead required CDISC and AdAM experience required • Coordinate biostatistical aspects of submissions to regulatory authorities; participate in presentations to regulatory reviewers. • Provide training on biostatistics-related topics to other disciplin...

The Medical Director provides medical administrative leadership to the division, working closely with his/her administrative director on; quality, safety and outcomes of patient care Alignment of physicians with SMG, operations, performance improvement and strategic goals; Program development Communication and access to care Budget development and resource management Professional development of the division physicians Development and promotion of SMG. The authority to act in these areas of responsibility is derived from SMG leadership, policie...

We are currently looking for a Medical Director/ Senior Medical Director specializing in Oncology to join our client's global Medical Affairs team. We are open to Oncologists (board certified US or foreign board certified) who are interested in moving their career into industry, helping to develop and bring out new drugs for cancer patients. These positions are home-based with minimal travel, and can be based in either the US or Canada. Working in a fast-paced, client-focused global environment, our Medical Directors play a pivotal role on our cl...

We are currently looking for a Medical Director/ Senior Medical Director specializing in Oncology to join our client's global Medical Affairs team. We are open to Oncologists (board certified US or foreign board certified) who are interested in moving their career into industry, helping to develop and bring out new drugs for cancer patients. These positions are home-based with minimal travel, and can be based in either the US or Canada. Working in a fast-paced, client-focused global environment, our Medical Directors play a pivotal role on our cl...

We are currently looking for a Medical Director/ Senior Medical Director specializing in Oncology to join our client's global Medical Affairs team. We are open to Oncologists (board certified US or foreign board certified) who are interested in moving their career into industry, helping to develop and bring out new drugs for cancer patients. These positions are home-based with minimal travel, and can be based in either the US or Canada. Working in a fast-paced, client-focused global environment, our Medical Directors play a pivotal role on our cl...

Our client, a mid-sized CRO and a great team of people, are currently looking for an Associate Director, Business Development to join the team! Position Description Summary The Associate Director, Business Development supports growth by developing new business opportunities, cultivating and maintaining client relationships, and achieving corporate sales objectives. Responsibilities Specific duties include, but are not limited to, the following: Business Development: • Generate and develop qualified business leads within assigned territory ...

Our client, a mid-sized CRO and a great team of people, are currently looking for an Associate Director, Business Development to join the team! Position Description Summary The Associate Director, Business Development supports growth by developing new business opportunities, cultivating and maintaining client relationships, and achieving corporate sales objectives. Responsibilities Specific duties include, but are not limited to, the following: Business Development: • Generate and develop qualified business leads within assigned territory ...

As a FISH - Laboratory Supervisor, you will have the overall responsibility for the planning, coordination, evaluation, and supervision of all technical and/or operational activities and personnel in the department. You will be responsible for performing duties to meet quality assurance, safety and accreditation requirements in the laboratory. The FISH - Laboratory Supervisor is also responsible for helping in the implementation of all area procedures and operations as well as ensuring that metrics established to measure quality, production and effici...

Our client, a growing pharmaceutical company, is looking for a Director/Senior Director of Regulatory Affairs to join their terrific team! Job Description: Reporting to the VP, Regulatory, the Director/Senior Director, Regulatory Affairs will be responsible for developing and implementing Regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. This individual will provide Regulatory leadership and a sense of urgency to cross-functional teams responsible for glob...

Will support formulation development work by developing, troubleshooting, and validating suitable analytical (LC, GC) test methods quickly and efficiently. Examples include assay and related subs methods for actives, fast LC methods for DDU and APSD, and GC and LC methods for excipients. Will perform hands-on lab work as well as direct, develop and train analytical scientists. Will provide routine characterization of R&D formulations and analytical support for studies necessary for chemistry, manufacturing and controls (CMC). In addition, will trans...

Senior Clinical Research Associate – Remote • Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and con...

Senior Clinical Research Associate – Remote • Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and con...

Clinical Site Manager • Experience Level 5 years Clinical Research experience (as centralized in-house monitor or onsite monitoring ideal) within multi therapeutic areas – particularly strong oncology or more complex diseases/trials (transplant, sepsis, HIV, etc.) • Degree requirements 1. Bachelor's degree in Life Sciences, Allied Health, Nursing or Pharmacy 2. Bachelor’s degree from an accredited university or equivalent. • Relevant Experience: 1. Thorough understanding of ICH/GCP guidelines and regulations as they relate to protocol/site mana...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the monit...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the mon...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site act...

• Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits. • Conducts Site Initiation visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements. • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators. • Critically reviews and analyzes site act...

Responsibilities and Accountabilities • Demonstrates innovative design, development, and execution of process development projects through literature review and scientific teamwork. • Assess and interpret experimental data using DOE and statistical techniques. • Develops robust, scalable, transferable processes for upstream production of rAAV clinical gene therapy vectors. • Serve as a Subject Matter Expert (SME) for the development of robust, high performing upstream processes with emphasis on transferability to cGMP manufacturing and sup...

12 month renewable contract - Remote - The minimum education requirement is a Master’s degree in Statistics, Biostatistics or other subject with high statistical content. - Min. 2 years of pharma/biotech experience with a PhD or 4 years with a master's degree - Experience in hematology, oncology or immunology therapeutic areas (at least one of those areas) - FDA or European regulatory experience and in-depth knowledge of regulatory regulations and guidelines. - Experience working on study protocol, study design, statistical analysis...

Flow Cytometry JOB openings in FL. The Flow Cytometry Technologist is responsible for daily specimen processing in the clinical flow cytometry laboratory. Communicates with staff physicians and other staff employees regarding patient specimens. Works with management personnel to ensure efficient and technically correct systems and procedures in the clinical cytometry laboratory that includes QA/QC of reagents, instrumentation, proficiency testing, etc. Qualifications Bachelor's Degree in Clinical Lab, Chemistry, Biology or related field and com...

This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs. The ideal candidate will provide hands-on programming and validation support to project teams Essential Responsibilities: • Program analysis datasets, statistical tables, figures, and listings. • Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation. • Provide statistical programming and validation support for clini...

POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, clinical operations, biostatistics, and programming and will oversee the work of statistics and progra...

The Senior Programmer is responsible for managing the inflow of a variety of healthcare claims and EMR databases, checking quality, developing specifications, transforming data to a common data model, and publishing data for use by statistical programmers, analysts and data scientists across the company. The qualified candidate must also be able to provide reports, presentations and detailed explanations to epidemiologists, analysts and programmers and work in collaboration with both internal and external partners. Prior experience with large ...

POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, clinical operations, biostatistics, and programming and will oversee the work of statistics and progra...

Position Summary Work in conjunction with the Director who has the ultimate authority and responsibility for the specific genetics' division. Help provide direction and leadership for the administrative, fiscal, technical and scientific responsibilities of the division. Help ensure the safe and efficient operation of the division's clinical diagnostic service. Help provide consultative services at an institutional level to departments, divisions, committees, and cancer center (scientific staff within Medical Center and BRI) scientists, as well as to ...

DOCS is hiring! Are you looking for a company that values their employees and promotes work/life balance? If so, we are looking for Senior Clinical Research Associates/Senior Site Managers. A Site Manager is the person in Trial Co-ordination and Site Management that serves as primary contact point between the sponsor and the investigational site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Pract...

Responsibilities: • Develop and implement overall marketing and sales strategy, subject to approval by the owners • Focus on medical device markets o One-stop shop approach: company provides all services needed for your medical device:  Regulatory Affairs  Quality systems  Concept development/ideation  Product development – engineering through qualification, fully compliant with national and international regulations  Product approval – regulatory agencies in US, Canada, EU, other  Product safety qualification – Nationally Recognized T...

remote, contract biostatistician, one year renewable contract with leading pharmaceutical company Top 3 Must Have Skill Sets: • Software Development Life Cycle experience • Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions, working with clinical development colleagues in study management, programming and IS • Experience in assisting the safety team with aggregated analysis for signal detection for ongoing studies Day to Day Responsibilities: Within the first 30 days a ...

This position will work closely with the Head of Biometrics in identifying project demands and resource needs. This role will be responsible for leading the Biometrics team, which includes programming and data management, to provide strategic, scientific and statistical leadership to the assigned clinical development program(s), with guidance from the Head of Biometrics. This role oversees statistical aspects of assigned projects to ensure that scientific, regulatory and quality requirements are met and that plans are aligned with development goals. T...

Senior Statistical Programmer 6 month renewable contract Key Responsibilities Writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create CDISC data sets, tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications Utilize SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Create all files, documents, and analyses necessary to support an electronic...

1 year renewable contract - Onsite NJ Develop, program, test and maintain clinical trial databases and data entry screens using Rave in accordance with standards Lead collaborative cross-functional team study build meetings for in-house and outsourced studies Review edit checks for in-house and outsourced studies Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and standards Participate in and lead team meetings when appropriate Act as primary CRO contact, when nece...

- 9 month potentially renewable contract - Onsite NJ CORE JOB FUNCTIONS: • Responsibilities will include analysis of clinical trial data with emphasis on translational data in addition to analysis of clinical, quality of life and of real world data. • Work under the direction of Medical Affairs Statistics Disease Lead. • Actively provide statistical support in the Medical Affairs Department, with emphasis on support of translational research. • Actively provide statistical support to the Medical Affairs Department. • This position coul...

- 1 year renewable remote contract The Senior Programmer is responsible for managing the inflow of a variety of healthcare claims and EMR databases, checking quality, developing specifications, transforming data to a common data model, and publishing data for use by statistical programmers, analysts and data scientists across the company. The qualified candidate must also be able to provide reports, presentations and detailed explanations to epidemiologists, analysts and programmers and work in collaboration with both internal and external...

- 12 month potentially renewable contract - Ideally onsite NJ but will consider remote Responsibilities will include, but are not limited to, the following: • Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. • Perform programming validation to ensure the qua...

- 12 month potentially renewable contract - Onsite Seattle Responsibilities will include, but are not limited to, the following: 1. Actively provide statistical support to the Clinical R&D Department. • Provide statistical input into the design of protocols including preparation of the statistical analysis section. • Prepare statistical analysis plans including table/listing/figure shells. Provide derivation for key variables and review data/programming specs. • Analyze and report results of clinical trials. Provide tables, listings and gr...

- Onsite San Diego - 6 month initial contract length CDISC Experience required NDA submission, ISS and ISE , big plus • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications. • Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files. • Perform quality control for SAS programs and other study documents (e.g., presentations and reports). • Maintain complete and auditable documentation of all programming activ...

DOCS Global is the premier resource provider in the biopharmaceutical and medical device industries. We currently have an exciting opportunity available in Montreal Canada. The Senior Site Manager serves as primary contact point between the sponsor and the investigational site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through ...

Duties & Responsibilities: • Follow Sponsor’s training, instructions, and reference documents for accurate filing of trial documents into Sponsor’s TMF • Manage the workload for assigned trials (approx. 5-7) • Work with the Clinical Trial Manager and trial team to identify and maintain the country and site specific List of Expected Records (LoER) • Perform quality checks on filed documents according to current standards and instructions • Track filing activities and quality checking results using Sponsor’s provided tools and instructions • Sche...

I am reaching out to you to inform you, your friends, or colleagues of an Clinical Geneticist job opportunity available in Westchester County New York. *ABMG required and NYSCoQ* If any interest, please forward your CV or Resume to me via e-mail at: jfoster@stafficons.com or please send me the referrals contact info or please pass this message on to them. See brief job description below: MEDICAL GENETICIST JOB OPENING IN WESTCHESTER COUNTY NY (30 minutes North of NYC) An exciting opportunity to join an established Comprehensive Medic...