Job Title

• Clinical Study Coordinator
  

Position Description

• 2 Study Coordinators 2nd Shift (3:00pm-11:00pm) including weekends and holidays.  They are a 7 day, 24hr site.  6mo contract to hire.  

Position Requirements

• Responsibilities include: Fountain Valley is in Orange County near Irvine.  Both candidates need to be fluent in Vietnamese.  Not conversational, fluent where they can speak and read in order to deliver informed consents to patient.
• Client needs a research nurse who has clear communicaitons skills in both languages.
•  Looking for more than 2 years of experience as a Coordinator at a site but will train a RN.  
• Must be able to produce certifications for Human Subject Training, GCP Training, Phlebotomy (if they have it).  
• No specific therapeutic area required.  This role is responsible for In Patient, highly complex trials.  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Clinical Trial Associate

Position Description

• Supporting Clinical teams on Study Management Related Tasks.

Position Responsibilities

• Supports project clinical teams by performing tasks related to study mgt from start up to study completion.
• Distributes collects and tracks study documentation and completes project deliverables accurately and within project timelines.
• Key role in supporting project team needs.
• Utilizes technology effectively to support clinical development processes.
• Develops mastery of relevant systems (e.g. Impact, study management tools, ESF, etc.).
• Identifies new innovative ideas and shares best practices.

Position Requirements

• Bachelors Degree
• 1-3 years experience

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• NIH Registration Analyst

Position Description

• Registering trials into NIH Website, and completing on the administrative tasks related to trial registration.

Position Responsibilities

• Register trials in accordance with the FDA Amendment Act (FDAAA) into the NIH website
• Responsible for the administrative tasks associated with registering a trial
• Work with clinical teams to resolve issues
• Work independently on projects, ability to assess and implement continuous improvement activities within the Clinical Trial Transparency Group
• Participate on committees / task forces
• Liaise with NIH to provide clarification on government requirements

Position Requirements

• 3-5 years of Clinical Site Management experience
• Experience with entering data into the NIH website
• Process improvement experience 
• Good people skills, strong computer skills, ability to work independently
• Excellent follow up skills, strong tracking and attention to detail skills

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• NIH Reporting Analyst

Position Description

• Assess scientific data contained in Clinical Study Reports, Medical Writer Experience Preferred.

Position Responsibilities

• Assess scientific data contained within the Clinical Study Reports
• Problem solve complex issues on how the data is to be displayed in the NIH system (www.ClinicalTrials.gov) by developing recommendations for the medical monitor and statistician to evaluate, enter results data into NIH database
• Meet with the clinical teams to provide guidance on reporting requirements
• Liaise w/ Statisticians & Medical Monitors
• Assist with the creation of job aides.

Position Requirements

• 5-10 years of medical writing experience
• Ability to interpret complex scientific documents
• Liaise with statisticians and medical monitors about scientific data
• Ability to be flexible, handle a high workload, work independently, be a critical thinker and problem solver, have strong communication skills and strong attention to detail and follow up skills.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• SAS Programmer

Position Requirements

• 5-8 years of pharma or biotech experience using SAS.
• Experience with all phases of clinical trials.
• Masters Degree in Statistics

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

• Clinical Publishing Lead

Job Title

Position Description

• Role Holder will have responsibility to design and implement innovative Health Economic and/or Outcomes Research activities and produce scientific evidence to optimize price and value proposition.  The role holder will assist communication efforts of value proposition and evidence to achieve maximal commercial success of products throughout their life cycle.  The role holder will have in-depth, specialist knowledge of Health Economics and Outcomes Research (HE&OR) and its application to pharmaceutical development throughout development process.
  

Position Responsibilities

• Evaluate and analyze information and generate high quality health economics and/or outcomes research input to the product profile and claims and value demonstration plan.
• Proactively and independently contribute to research planning process and resolution of complex issues, which may impact market access decisions and evidence for product.
• Member of the Value Demonstration Work Stream if applicable.
• Interact with cross-functional team members at a project level.
• Supports Clinical Project Team (CPT).
• Manage HE&OR activities as designated by HE&OR team leader.
• Assist study team personnel and associates in patient reported outcome instrument development and/or administration and or model development.
• Identifies external HE&OR data sources and literature references.
• Prepares proposal requests for Health Economic and Outcomes Research work projects and manages selection process. 
• Budgeting accountability for sub-projects within the health economic project team. 
• Prepares technical presentations.
• Assists in writing preparations, references, and development of  reimbursement/formulary documents.
• Prepares HE&OR data as background materials and registration pack for discussion with regulatory authorities. 
• Advances knowledge about health economics and outcomes research and the impact of pharmaceutical product development.
• Advance expertise in health economics and outcomes research through presentations, publications.
• Adaptation of global core value documents, communication materials, publications for use with US decision makers and purchasers.
   

Position Requirements

• Bachelors degree in clinical, biological, or social sciences.
• Masters degree in relevant field (outcomes research, health services research, epidemiology, health economics, health policy or related fields)
• Doctoral degree in relevant field preferred.
• Ten years of relevant experience, five of the years in the pharmaceutical/medical industry.
• Two years previous project experience in Health Economics and/or Outcomes Research.
• Previous project management or personnel management preferred.
• In-depth specialist knowledge of Health Economics and/or Outcomes Research and its application to pharmaceutical development at an international level.
• Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective and product development processes at all life cycle stages. 
• Knowledge of international healthcare systems and their changing needs for health economic and patient-reported outcomes information. 
• Strong knowledge of legal and regulatory environment influencing clinical development plans, labeling and promotional claims.
• Proactive application of therapeutic area and disease treatment knowledge.
• Able to implement projects including key stakeholders with high degree of autonomy.
• Excellent written and verbal communication skills.
• Requires high level of interactive communication including challenges to conceptual thinking as necessary. 
• Communicate  project plans to commercial stakeholders.
• Proven teamwork and collaboration skills.
• Well-developed cultural sensitivity.
• Effectively represents the company externally to key
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Statistician 

Position Responsibilities

• Skilled scientist with training and significant experience in statistics, drug development, and clinical research.
• This position will provide opportunities for independent and/or leadership contributions to clinical trials and drug development programs.
• The Statistical Consultant needs to be knowledgeable about statistical principles and appropriate software and tools to perform his or her tasks.
• He or she is expected to work collegially and closely with clinical research staff and senior statistical staff to determine appropriate study designs, sample size estimates, and write appropriate sections of study protocols.
• The position is also responsible for writing statistical analysis plans, analyzing data, and writing sections of clinical study reports and registration documents. .
  

Position Requirements

• Ph.D. in Statistics/Biostatistics (or related field), or MS/MA with a minimum of 2 years of experience, is required.
• Good presentation and written communications skills.
• Ability to communicate with non-statisticians to interpret statistical findings 
• He or she must have excellent written and oral communication skills
• Good organizational and problem-solving skills.
• Ability to program proficiently using SAS
• Ability to write SAS programs to perform efficacy and safety analyses
• Knowledge of CDISC SDTM and ADaM
• Knowledge of relevant FDA and CHMP guidelines
• Experience with regulatory submissions in the US
• Experience with regulatory submissions outside the US desirable
• Knowledge and understanding of therapeutic-specific regulatory guidelines and perspective is preferred.
• Knowledge of techniques for demonstrating non-inferiority and bioequivalence highly desirable.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Clinical Services Manager

Position Description

• Provide Post Sales Account Management to CTMS customers.  Strong understanding of CTMS systems is critical, with a background in clinical research. 

Position Responsibilities

• Support the development and implementation of key projects. 
  Manage, maintain and serve as primary contact for existing customer relationships;
• Develop and execute on account strategies
• Identify/confirm the customer’s business needs/drivers
• Identify other potential users (ex. expansion opportunities)
• Identify potential inside competition (ex. systems, initiatives, dissenters, re-organizations)
• Identify consult needs and lead the delivery of Study Consult Services (SCS) to customer
• Expand understanding and use of company’s software within existing customers, including customer’s Executive team
• Identify new opportunities within existing customers (i.e. new products) and secure referrals to other opportunities

Position Requirements

• BS/BA degree plus 5 years direct pharmaceutical clinical research experience (primarily as a CRA/Clinical Trials Manager and/or Clinical Operations Manager)
• 5+ years experience in clinical operations, clinical trial project management, clinical trial costing, and/or clinical outsourcing/contract negotiation
• Strong entrepreneurial drive and ability to deliver results with limited supervision
• High energy, self-motivated, assertive; consummate professional
• Good customer presence and presentation skills
• Able to understand/analyze customers [unstated] needs.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

Position Description

• The Medical Writer III is responsible for the coordination, preparation, and completion of Periodic Adverse Drug Reports (PADERs), Periodic Safety Update reports (PSURs), and other ad hoc safety documents for submission to regulatory agencies around the world. The Medical Writer III is also a team leader providing guidance in safety writing procedures and training.
  

Position Responsibilities

• Assist in the management of safety writing report timelines, resources, and project workload
• Assist in the training of safety writing team members, providing functional expertise and guidance
• Write and prepare standalone postmarketing aggregate safety documents for regulatory submission, such as PSURs and associated documents, and PADERs
• Ensure all safety regulatory documents are processed and submitted according to regulatory requirements
• Ensure data issues are addressed and resolved prior to document sign-off
• Facilitate document review by other contributors
• Assist with the creation and maintenance of standardized departmental procedures concerning the writing of Safety reports and processing of the reports for regulatory submission
• Participate in ongoing safety data review and analysis for products in designated therapeutic areas
• Collaborate with medical reviewers, epidemiology, and risk management concerning safety issues relative to safety writing activities
• Interface with other functional groups such as Regulatory Affairs, Quality, Information Technology, business units, as needed
• Lead or participate in project teams and committees as assigned
• Act as therapeutic area team leader
• Demonstrated leadership in a team environment
• Experience preparing postmarketing safety regulatory documents such as PSURs and associated documents, and PADERs
• Knowledge of global postmarketing safety reporting regulations and guidances
• Experience with coding dictionaries such as MedDRA
• Excellent scientific writing skills

Position Requirements

• Bachelor’s degree in a medical / scientific field plus at least four (4) years pharmacovigilance experience, or a Master’s degree plus at least two (2) years pharmacovigilance experience
• Previous experience writing PADERs and/or PSURs
• Exposure to a working relationship with FDA and other regulatory authoritiesmeeting expectations of regulatory authorities for aggregate safety reports
• Experience writing in an academic research, clinical research, scientific/analytical, or medical affairs setting is a plus
• Proficiency for the following competencies are key to success in the Risk Management Group.
• Scientific and Technical Analysis  - Provide Guidance to internal project teams in the area of design and analysis for more complex or high risk projects
• Submission Project Mgmt – Provide direction and guidance to more junior staff in response to complex AE reporting and content, documents, timeline
• Product/Process Quality Standards - Oversee the education of internal stakeholders on implications of regulations
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Sr. Statistical Programmer

Position Description

• The purpose of this position is to provide study-level statistical programming suppor
• Executing analysis deliverables to meet the requirements of clinical studies.
• Enforcing standardization of derived datasets and analysis outputs to maximize global data integratability.
• Directing the work of external vendors providing statistical programming services to achieve quality and timely, cost-effective study deliverables.

Position Responsibilities

• Represent the statistical programming function in support of assigned clinical studies
• Define and manage derived data set and reporting standards for common clinical studies using respective company standards.
• Develop, execute, and maintain routine SAS computer programs according to Statistical Analysis Plans (SAPs) or analysis requests to: Produce statistical analysis output (tables, listings and graphs) to support generation of critical (flash) clinical study results or ad-hoc analyses involving descriptive statistics; Perform standard data manipulations, including creation of derived data sets, related to the production of the statistical output; Verify (QC) simple study analysis results or derived data sets produced by another statistical programmer, statistician, or an external vendor.
• For assigned common clinical studies, identify vendor requirements and participate in the evaluation/selection of Analytical Sciences vendors. Provide technical oversight of statistical programming activities of external vendors to assure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical programming vendor deliverables. Seek advice of senior peers, the manager, or the study statistician, if needed, in overseeing the vendor activities and review of outputs.
• Manage transfers of all externally produced analysis data and outputs.
• Archive statistical outputs and related documentation according to company standards
• Anticipate and communicate resource and quality issues that may impact deliverables or timelines. Escalate issues to senior peers or management as appropriate and implement solutions.
• Support implementation of programming utilities, data and output standards and improvements to the statistical programming environment.
• Comply with all applicable regulatory requirements,standards and procedures.

Position Requirements

• BS in Statistics, Computer Science, or other related field with minimum 2years SAS programming experience in the pharmaceutical/CRO industry; or MS in Computer Science, Statistics, or other related field with minimum 1 year SAS programming experience in the pharmaceutical/CRO industry.
• Good knowledge of SAS programming language and Base SAS, SAS/GRAPH parts of SAS software, knowledge of simple procedures in SAS/STAT.
• Good understanding of general programming and computing principles, experience with Windows NT and UNIX operating systems, and common software products and technologies used in conjunction with SAS; working knowledge of office software (Microsoft Office).
• Understanding of clinical study documents (protocol, CRF, SAP, Clinical Study Report).
• Understanding of clinical study designs, common analysis methods, descriptive and simple inferential statistics, and data presentation practices.
• Understanding of data management processes, including EDC processes, documents and data flow in clinical trials.
• Basic understanding of drug development process.
• Knowledge of FDA and ICH regulations and industry standards applicable to clinical study data and reporting on clinical trials, including data standards for electronic submissions.
• Basic project management skills.
• Good oral and written communications skills.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• CMC Manager

Position Description

• This individual is expected to provide leadership within Regulatory Affairs and will be responsible for actively contributing to the development and implementation of CMC regulatory strategy for products in development as well as coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or programs.
• This person will serve as the regulatory CMC representative on relevant project teams.

Position Responsibilities

• Develop global CMC regulatory strategy for development products.
• Direct management of assigned development programs.
• Drive all CMC submission activities (IND, CTA, NDA, BLA) and health authority interactions (meeting requests and briefing documents).
• Represent Regulatory Affairs at various project team and working group meetings.
• Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
• Expected to develop and manage project timelines as well as have the ability to multi-task.
• Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic.
• Contribute to the development of comparability protocols, validation protocols, and stability protocols.
• Ensure the quality and content of all submissions to health authorities.
• Liaise with partnering companies to ensure regulatory alliance.

Position Requirements

• Position requires a minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful.
• Must have a minimum of 6 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry.
• Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements; EU, Canada, and ROW experience highly desirable.
• Previous experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with regulatory authorities is also required.
• Candidates must be able demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and verbal)

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance