Job Descriptions in Clinical Research, Regulatory Affairs, & Medical Affairs
Source: BayBio Institute
Clinical Research Associate
Is key participant in the design, implementation and monitoring of clinical trials, preparation of integrated medical reports, INDs, Investigational Device Exemptions (IDE), periodic reports, New Drug Applications (NDAs) and Biological License Applications (BLAs), etc. Participates in design and writing of protocols, case report forms and informed consent forms for clinical trials. Productive in recruitment/selection of new investigators, contract research organizations and outside vendors. Responsible for planning and implementing all activities required to conduct and monitor complex clinical trials and ensures that Good Clinical Practices (GCP) are followed. Conducts site visits pre-study, at study initiation, at regular intervals during the study and at study closeout. Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary.
Ensures that Case Report Forms (CRF) are reviewed in a timely fashion and submitted to the data management group. Involved in the compilation/writing of integrated medical reports and clinical sections of INDs, IDEs, New Drug Applications (NDAs) and Biological License Applications (BLAs), etc. Assists in preparation of presentations and manuscripts of scientific meetings and technical journals. Attends scientific/professional meetings and training courses as appropriate.
Senior positions require BS in a scientific, health care field (e.g., nursing, pharmacy, physician's assistant), or related field and 5 - 8 years experience in the pharmaceutical or device industry including relevant clinical research experience.
Intermediate positions require BS in scientific field and 2 - 4 years related experience.
Knowledge of FDA regulatory requirements is preferred for both Senior and Intermediate levels.
Medical Director/Associate Medical Director
Designs, implements and monitors clinical studies of compounds designated for clinical development. Develops protocols and case report forms, which will provide adequate efficacy and safety information for Phases 1 to 3 of clinical trials. Interacts with data management personnel to plan data entry and analysis; recruits/screens/selects competent investigators; organizes investigators' meetings; assures that Good Clinical Practices (GCPs) are followed; assures timely completion of studies; monitors data for safety and efficacy trends by reviewing clinical data; and writes clinical reports upon completion or termination of studies (in cooperation with statistical staff). Reviews requests for results of Investigational New Drugs (IND) studies, and provides input for pharmacokinetics and pre-clinical studies.
Prepares clinical portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios. Plans clinical programs and develops a timetable, budget and resource analysis for clinical programs and personnel administration. Establishes and maintains relationships with alliance partners, external companies, investigators and opinion leaders to optimize performance on clinical trial activities. Prepares manuscripts for technical journals and makes presentations at scientific meetings.
Medical Directors require a MD/PhD in a relevant scientific discipline and a minimum of 5 - 8 years experience in clinical research. Associate Medical Directors require a MD/PhD and 0 - 3 years clinical research experience. Pharmaceutical experience is desirable.
Clinical Research Manager
Supervises design and writing of protocols, case report forms and informed consent forms for clinical trials. Supervises and directs the design, implementation and monitoring of clinical trials, preparation of integrated medical reports, INDs, Investigational Device Exemptions (IDE), periodic reports New Drug Applications (NDAs) and Biological License Applications (BLAs), etc. Makes decisions on recruitment/selection of new investigators, contract research organizations and outside vendors. Directs planning and implements all activities required to conduct and monitor complex clinical trials and ensures that Good Clinical Practices (GCP) are followed. Monitors site visits pre-study, at study initiation, at regular intervals during the study and at study closeout. Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary.
Ensures that Case Report Forms (CRF) are reviewed in a timely fashion and submitted to the data management group. Monitors the compilation/writing of integrated medical reports and clinical sections of INDs, IDEs, New Drug Applications (NDAs) and Biological License Applications (BLAs), etc. Prepares manuscripts for technical journals and makes presentations at scientific meetings.
Requires a BS or MS in a scientific or health care field (e.g., nursing, pharmacy, physician's assistant) and 5-8 years plus experience in the pharmaceutical or device industry including relevant clinical research experience.
Responsible for the statistical integrity, adequacy and accuracy of the clinical studies/databases. Provides guidance in statistical analysis methodology and performs statistical programming, design, and analyses for clinical trial projects. Plans, coordinates and provides statistical analyses, summaries and reports of studies in the support of product development including IND/ New Drug Applications (NDAs) and Biological License Applications (BLAs) submissions. Maintains and improves professional knowledge of technological advancements in data manipulation and statistical analyses.
Senior positions require an MS, a PhD is preferred and 4 - 8 plus years experience in clinical trials, regression models, survival analysis and analysis of categorical data. Ability to manage several programs and protocols is required for senior positions.
Intermediate positions require BS/MS and 2 - 5 years related experience.
Both levels require good communication and interpersonal skills and a background in SAS and other programming skills. Application of these skills in a pharmaceutical environment is preferred.
Clinical Data Manager/Associate
Primary responsibility is to ensure the validity of clinical trials and format them for statistical purposes. Also designs collection instruments, sets up databases and tracks and manages the flow of data to and from the investigative sites. With supervision, establishes protocol-specific data review and entry guidelines to document data validation and formatting procedures and defines batch-ending programs. Monitors timely data entry. Reviews data discrepancies resolutions provided by the investigative sites and enters corrections in the database, as appropriate. Assists in the review of interim/final data listings prior to transmission to other groups or inclusion in interim/final reports. Is familiar with database management systems and the principles, organization and content of standard Case Report Form (CRF) libraries. Ensures that incoming CRFs are tracked in a timely manner prior to safety review and upon manual review. Is familiar with data coding of Standard Operating Practices (SOP) and coding dictionaries. Conducts database audits according to established SOPs and is familiar with the implementation of GCPs.
Entry-level positions require a high school diploma or Biotech Certificate and 2 - 5 years experience in clinical data management or a BS with 0 - 2 years related experience.
Intermediate positions require a BS and 1 - 3 years clinical data management experience, senior positions require a BS/MS with 3 - 6 years related experience.
Managerial positions require a BS/MS with 5 - 8 years clinical data management experience.
Experience with use of a personal computer and a range of software applications is necessary. Database management experience is helpful.
Clinical Database Manager/Programmer Analyst
Works as part of a project team, or possibly as a team manager, to design and implement applications in support of clinical research and biostatistics. Leads the analysis, design and implementation of client-server applications such as Oracle, SQL and forms of GUI-based products. Develops forms, menus and reports based on functional and design specifications. Documents all work fully according to Clinical Information Systems (CIS) standards. Actively promotes standards for the development and acquisition of systems. Participates in the evaluation and implementation of packaged systems. Communicates with the end-users.
Programmer/Analyst positions require BS in computer science or related field and 0 - 3 years programming experience, preferably in the pharmaceutical or health care industry.
Senior Programmer/Analyst positions require BS/MS in computer science or related field and 2 - 5 years related programming experience.
Managerial positions require BS/MS in computer science or related field and 5 - 8 years related experience.
Responsible for the timely preparation, production and quality control of regulatory documents, including coordinating with regulatory project teams, creating editorial timelines and work flow specifications, scheduling and tracking documents, assessing documentation staffing needs, participating in "round-table" review of documents, establishing project-specific style guidelines, editing at various levels, writing and proofreading. Develops and updates specifications for the design, format production elements, tracking of regulatory documents and artwork used in regulatory documents. Hires, trains and supervises editorial temporaries and coordinates their work. Develops and updates departmental editorial style standards by preparing and revising a style guide. Provides guidance on writing to authors of regulatory submissions, and develops and updates general writing guidelines by preparing and revising an author's guide. Participates in Computer Application for New Drug Application/Computer Application for Product License Application (CANDA/CAPLA) planning pertaining to document structures.
Senior positions require BA/BS/MS and 5 - 8 years plus publications experience, including at least 3 years in a scientific or technical publishing environment.
Intermediate positions require BA/BS and 3 - 5 years related experience.
Direct experience in FDA regulatory documentation is desirable for both levels.
Director/Manager of Regulatory Affairs
Responsible for long- and short-term planning and directing of regulatory activities. Interprets corporate policy, develops and implements strategies for the earliest possible approval of regulatory submission, advises and manages the regulatory teams, and reviews ongoing projects. Plans, schedules and directs activities and programs through regulatory staff. Negotiates with outside agencies (national and international) as needed to resolve key regulatory issues and expedite approvals of product and services.
Reviews and prepares responses to inquires from regulatory authorities relating to product registrations. Monitors and updates national and international registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel. Communicates pertinent changes and updates to regulatory staff and senior management. Oversees the preparation and submission of applications and routine reports/renewals, including the preparation and submission of supplements and amendments as required by internal department (Manufacturing, QA/QC, Medical, etc.) to update registered product information. Provides input on budget requirements, and monitors project and program costs. May hire, train and develop regulatory staff and provide input on associated compensation and department structure decisions.
Director levels require a BS/MS in a scientific discipline, a PhD is preferred and 10 years experience.
Managerial levels require a BS/MS in a scientific field and 8 years experience.
Regulatory Affairs Associate
Ensures all company products meet worldwide regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations/ interpretations. This may include the review, evaluation, and compilation of files and reports for submissions. Provides project team representation and direction in managing information from/to other departments (including R&D, Manufacturing, Quality Assurance, Quality Control, Medical Affairs, Marketing, and Clinical Affairs) regarding Regulatory submissions.
This may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments. Reviews technical and clinical documentation and recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Is responsible for the timely completion of regulatory projects and submission of documentation to regulatory agencies. Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes. May provide regulatory guidance to project teams and junior staff.
Senior positions require BS/MS and 5 - 8 years plus regulatory affairs experience in the development of biological or pharmaceutical products.
Entry-level and intermediate positions require a BS/MS and 0 - 4 years related experience.
In-depth knowledge of FDA laws is desirable for both levels.
Responsible for coordination and administration of document production procedures, including planning and scheduling of word processing and production resources. Coordinates with project teams in the development of timelines for documentation phase of regulatory submissions. Is responsible for management of electronic files. Coordinates with scientific editor to develop and update specifications and procedures for design and format of documents and artwork policy and procedures. Oversees reference collection, archive system, and produces monthly and annual reports of regulatory submissions. As Local Area Network (LAN) administrator is liaison with bioinformatics and information systems departments and is responsible for computer hardware and software setups and maintenance. Participates in capital budgeting and in planning regarding CANDA/CAPLA systems.
Intermediate positions require a BS and 2 - 4 years related experience in a scientific or regulatory environment and senior positions require a BS/MS and 5 - 8 years related experience.
Entry-level positions require a high school diploma or Biotech Certificate and 1 - 3 years experience with computers and a LAN in a scientific or regulatory environment or a BS with 0 - 2 years related experience.
Medical Affairs Director
Oversees the management of Medical Affairs Department including, updates of operating SOPs, attainment of quality and financial standards, budget preparation, personnel training and development, and overall coordination of medical monitoring operations. Responsible for providing medical monitoring for ongoing clinical trials; communicating with investigators, sponsors, and clinical research personnel. Resolves medical issues, provides medical input for medical documents, supports business development activities and provides Serious Adverse Event (SAE) consultation. Maintains professional knowledge and skills, particularly in the areas of FDA/ICH guidelines and regulations.
Requires an MD with a minimum of 5 years medical experience and 3 years experience in the pharmaceutical or contract research industries.