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Catalyst Pharmaceutical Research is a fast-growing niche CRO specializing in providing growing pharmaceutical and biotechnology companies with cost-effective solutions to launching pharmaceutical development programs in the United States. Catalyst provides competitive pay and a full range of benefits including medical, dental, vision, 401K, LTD, Life, 10 paid holidays, sick leave, and vacations.

Currently, we have the following openings:


Clinical Project Manager

The Clinical Project Manager is responsible for setup, management and administration of clinical trials. Your duties will include:

  • Managing the daily in-house operations associated with the studies.
  • Overseeing monitoring activities.
  • Managing investigative site contracts and compliance, and managing clinical supplies.
  • Assuring adherence to corporate SOPs, Good Clinical Practice and FDA regulations by clinical staff, external vendors, and other parties involved in the conduct of clinical trials.

As a clinical research representative you will be required to interface with the sponsor's project manager, external vendors, and internal representatives from the other key functional groups such as regulatory affairs, data management and other clinical project groups to maintain and continuously improve the quality of corporate processes. You will be responsible for ensuring that internal departments such as Regulatory, Data Management have a clear communication path with the clinical department.

Some travel required. Clinical trial software and electronic data capture experience a plus. This person reports directly to the Vice President of Clinical Research

Requirements

B.S./M.S./Ph.D. in medical related/science fields or M.D. required, with at least 2 years clinical trial management experience. Must have worked for a large CRO and have pharmaceutical back ground.


Biostatistician

The Biostatistician will report directly to the head of Biostatistics and will work closely with SAS programmers, Clinical Data Managers, and the internal clinical team.

Responsibilities

  • Provide extensive biostatistical support in the planning, design, analysis, and preparation of reports for clinical studies.
  • Interact with clinical team, data management and medical writers in planning, conduct, evaluation, interpretation, and presentation of study results.
  • Develop and author Statistical Analysis Plans (SAPs) for FDA submissions.
  • Review and provide statistical expertise on key project documents (protocols, reports, data management plans, etc).
  • Furnish responses on statistical issues raised by regulatory agencies or other parties (sponsors, steering committees, etc).
  • Develop SAS programs to execute planned or ad hoc statistical analyses.

Requirements

PhD or MS in statistics or biostatistics. At least 2 years of working experience in clinical trials. Familiar with regulations and the standard of pharmaceutical industry. Must have sound knowledge of applied statistics and demonstrate the ability to integrate statistical and biomedical concepts. Strong computing and hands-on SAS programming skills. Capable of learning new concepts fast and carrying out assigned tasks with minimum supervision. Good understanding of statistical concepts and ICH guidelines.

Knowledge, Skills & Abilities Required

Knowledge of clinical data with general understanding of database structure and industry standard; hands on working experience with clinical database management systems in a pharmaceutical research environment is a plus; familiar with standard coding dictionaries (MedDRA, or WHOART, etc). BS/BA degree in life science or health-related fields. Detail oriented and computer literate. Good communication skils are a must.


Director of Quality Assurance and Regulatory Compliance (Location: Pasadena, CA)

Salary Range: $80,000 to $120,000

Summary Description:

Following significant growth, we are looking for a regulatory affairs professional to join our central strategic team in Pasadena CA as the Director of Quality Assurance and Regulatory Compliance. This position reports directly to the Vice President of Operations of Catalyst Pharmaceutical Research, LLC. In this role you will take the lead in planning, leading, and implementing the company's QA and compliance initiatives.

Key Responsibilities

  • Responsible for developing and implementing strong Standard Operating Procedures (SOP’s) and Quality Manuals for all departments to include the US and ICH regulatory requirements relating to, but not limited to: study start-up; clinical site selection; protocol development; Case Report Form development; database selection, programming and documentation; database validation; data collection and cleaning; data analysis and report generation; conduct of Clinical Events Committees, Data Safety Monitoring Boards, Scientific Steering Committees and Clinical Investigation Meetings.
  • Providing support prior and during regulatory inspections. Responsible for current knowledge of US/ICH clinical regulatory requirements and interpretation of such regulations in their application to the day-to-day operations of the Phase II and III operations.
  • Responsible for Clinical/Quality/Compliance (GCP) programs and issues relating to ongoing clinical studies and serve as regulatory resource to staff during all phases of clinical study management.
  • Managing Good Clinical Practices (GCP) compliance activities and training programs through the development of Clinical Quality Plans for all drug development programs.
  • Effectively advocate strategic quality systems approach and lead the organization in compliance.
  • Oversee due diligence and qualification efforts in the selection of vendors to provide clinical services including: electronic data capture; laboratory services; clinical site services; and other personnel or operations services as required. Ensure proper documentation of such due diligence and qualification efforts.
  • Plan for and administer all Sponsor and regulatory authority (FDA or other) audits and reach successful outcomes through diligent follow-up with these entities and process changes (as required) within the company.
  • Develop and administer staff training programs in regulatory compliance, including all aspects of FDA and ICH clinical trial requirements.

Knowledge, Skills and Abilities Required

You must possess thorough knowledge of US and EU regulatory aspects of clinical research including: Good Clinical Practices (FDA & ICH), Good Documentation Practices, Clinical Trials Directive, Authorized and Legal Representatives, Ethics Committees and Competent Authorities. You must have an understanding of the complexities of the Pharma development business and the ability to apply and communicate this understanding with regards to quality, compliance and regulatory requirements related to clinical development. Skill in writing departmental Standard Operating Procedures and Regulatory/Quality Manuals is critical. You must be capable of developing and executing quality and compliance training programs for all departments. Experience in setting up control of Standard Operating Procedures and compliance documentation.

Education and Experience

Successful candidates will ideally possess a life science or pharmacy degree (advanced degree preferred) with a minimum of 7 years Clinical QA(GCP) experience as well as some CRA specific experience. Prior management experience in implementation and regulatory compliance oversight of Phase I –IV clinical studies is preferred. Consideration will also be given to those individuals that have less experience but are looking to learn fast in a dynamic customer-orientated environment.

NOTE: Please submit your resume ONLY if you meet the qualifications as outlined.

Submit your resume by email to: [email protected] or by mail/fax to: Catalyst Pharmaceutical Research LLC, 1111 S. Arroyo Pkwy, Suite 200 Pasadena, CA 91105 626-568-8667. If you meet the requirements you will be contacted by Judy Greenwood – Human Resources to set up an interview. Recruiters, please do not call.

Clinical Data Manager

Summary Description:

The Clinical Data Manager (CDM) plays a pivotal role in FDA regulated clinical trials. The primary responsibility of the CDM is to ensure quality data that meet the agency/industry standard and satisfy the study/sponsor requirements. Specific responsibilities and roles of a CDM include: provide input and expertise in Case Report Form design, database setup, edit check specification; perform data management tasks from study start up through database lock; interact with a cross-functional team to establish data review guidelines and data flow procedures; monitor and track the data collection process; review patient data entered into the central database; coordinate with vendors and study managers to ensure deliverables meet the requirements of time and quality; trouble shoot data collection/management process deficiencies; determine appropriate course of action for resolving data errors in a timely manner; track validation discrepancies through collaboration with clinical study managers; prepare database lock upon completion of the study; develop and maintain study-specific documents (Data Management Plans, Data Review Guidelines, etc).

Requirements:

Working knowledge of medical terminology and familiar with clinical data; general understanding of database structure and industry standard; hands on working experience with clinical database management systems in a pharmaceutical research environment perferred; previous EDC experience is a plus; familiar with standard coding dictionaries (MedDRA, WHOART, etc); BS/BA degree in life science or health-related fields; attention to details and accuracy; capable of working independently with minimal supervision; adequate computer skills and excellent communication skills.

Note: Please submit your resume ONLY if you meet the qualifications as outlined.

Submit your resume by email to: [email protected] or by mail/fax to: Catalyst Pharmaceutical Research LLC, 1111 S. Arroyo Pkwy, Suite 200 Pasadena, CA 91105 626-568-8667. If you meet the requirements you will be contacted by Judy Greenwood – Human Resources to set up an interview. Recruiters, please do not call.


Manager, Clinical Data Management

Job Description:

In this capacity, the individual will provide leadership and expertise to the data management group and other internal and external cross-functional team members. The candidate will function as an operational manager to ensure that the data collection process is in compliance with regulations and industry standards and that quality data are delivered per project specifications and within timeline requirements. This position will report to the head of the Biostatistics and Data Management department.

Responsibilities:

  • Oversees and plays an active role in day-to-day operations related to data management activities 
  • Assists department head in directing, managing, and coordinating data management activities in collaboration with interdepartmental team members for timely, efficient, and high quality deliverables
  • Manages the workload and allocates resources effectively based on priorities and timelines per contractual agreements with clients
  • Recruits, motivates and coaches direct reports to ensure high quality performance and to meet growing demand for data management services
  • Takes initiatives and develops standards for a streamlined process through creating/modifying quality control procedures and SOPs to improve the efficiency of the process and the quality of delivered product
  • Reviews/approves data management documents and performs pertinent tasks as needed
  • Coordinate with vendors and study managers to ensure deliverables meet the requirements of time and quality
  • Functions as an advisor and resource on all projects that require data management support and provides strategic solutions to completing tasks
  • Provide input to and undertake implementation and maintenance of global working practices and standards to promote understanding, quality output and productivity

Requirements:

  • College degree with at least 5 years of relevant working experience
  • Ability to mentor and to coach within Data Management and crossfunctional teams
  • Perform internal and external training for entry level staff or other department team members
  • Good knowledge and general understanding of regulations in drug development with a focus on clinical data management in regulated clinical studies
  • Good inter-personnel skills and proven team building techniques with a minimum of 1 year supervisory experience
  • Excellent written and oral communication skills
  • Solid and hands-on computer skills with proven record of successfully bringing solutions to complex issues in a timely and effective manner

Note: Please submit your resume ONLY if you meet the qualifications as outlined.

Submit your resume by email to: [email protected] or by mail/fax to: Catalyst Pharmaceutical Research LLC, 1111 S. Arroyo Pkwy, Suite 200 Pasadena, CA 91105 626-568-8667. If you meet the requirements you will be contacted by Judy Greenwood – Human Resources to set up an interview. Recruiters, please do not call.


We offer competitive salaries. Relocation available. Please email your resume to [email protected].

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