Quality Control Manager

Summary: This position is responsible for contributing to the assurance that clinical trials are conducted, and data is generated, documented, and reported in compliance with internal standards, ICH/GCP, and applicable FDA regulatory requirements. Performs duties in accordance with company’s values, policies, and procedures.

Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion.

• Responsible for performing extensive quality control review of applicable study documents and data. This may include review of data that affects subject safety and data integrity, but is not limited to the following: protocol-specific source documents, inclusion/exclusion criteria verification, e.g. adverse events, concomitant medications, laboratory, and case report form (CRF) review/verification.
  • Communicate findings from QC reviews to the appropriate site staff via QC summaries, reports or verbally as required.
  • Follow-up on all QC findings, as required, until a satisfactory resolution has been determined.
  • Assure documentation review meets or exceeds designated timeline parameters.

• Responsible for overseeing processes and procedures to ensure compliance with applicable federal regulations and state laws for the protection of human research subjects. Follows guidelines presented in ICH E6 for good clinical practice (GCP), including but not limited to:

• • Attends specific site initiation visits.
  • Attends study specific source review meetings and study update meetings, as necessary.
  • Facilitates day-to-day quality control activities.
  • Development of risk-based, study specific source document quality control plans.
  • Maintains quality control spreadsheets and tools.

• Performs other quality management responsibilities as needed.

• • Enforces subject safety procedures and consults with supervisors about any identified issues.
  • Ensures that client and participant confidentiality is maintained.

• QC Metrics
  • Responsible for creation and maintenance of quality control monthly and quarterly metrics.
  • Assists in error tracking and trending.
  • Compiles data tables and summaries as requested. Compiles protocol and Standard Operating Procedures (SOPs) deviations, if requested. Communicates deviations from protocol and SOPs to management.
• Assists in the QC of source document templates against operation manuals and protocol.
• Responsible for being aware of total quality in other areas and providing comments and suggestions to site management and CRU Quality Assurance team.
• Contributes as a member of cross functional project teams, involved in quality improvement, including but not limited to: QC of data, fostering team building, positive communication, and corporate culture.
• Responsible for development and maintenance of good documentation practice (GDP) training materials for CRU staff.
• Responsible for conducting GDP training for new hire orientation, bi-annual or ad hoc training sessions,
• Responsible for regular tracking and maintenance of GDP training records.
• Conducts other quality control trainings in order to improve overall quality of CRU output.
• Ensures work carried out is in strict accordance with relevant protocols and SOPs and that internationally required standards of GCP are met.
• Responsible for keeping up-to-date with the current FDA and ICH requirements and guidelines.
• Provides guidance and feedback to site management and CRU Quality Assurance on strategies to meet these requirements.
• Assists Quality Leadership as needed.
• Any other duties as assigned by the Director, Clinical Study Management and/or manager or supervisor.

Competencies:

• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets firsthand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
• Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience:

Associate degree in life sciences or related field with at least one year of research experience in the clinical area of a pharmaceutical, CRO, medical device company, or related organization. A significant work history in clinical research with a demonstrable knowledge of GCP and GDP principles may be considered in lieu of an associate degree. Basic understanding of ICH/GCP guidelines, including a basic understanding of regulatory requirements and the clinical trial process or equivalent combination of education and experience is required. Experience working in QA/QC department reviewing clinical trial documents and data (source data and regulatory documents), knowledge of medical terminology, clinical research acronyms, and medical/scientific abbreviation and writing Standard Operating Procedures (SOPs) and/or Work Instructions (WIs) is desired.

Skills, Knowledge, and Abilities:

Working knowledge of FDA 21 CFR regulations for clinical research as well as ICH, GCP guidelines; demonstrated leadership skills; strong judgment, initiative, and problem-solving skills. Ability to perform clinical data review of source documents and case report forms independently and accurately. Ability to follow study specific guidelines, plans, and manuals, and participate in all aspects of training in addition to performing verification and resolution of data queries/discrepancies within defined timelines. Excellent written and oral communication skills. Ability to work to strict deadlines, prioritize, and remain calm under pressure. Diligently pays attention to details and pursues quality in accomplishing tasks.

Language Ability:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, employees, and the general public.

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills:

To perform this job successfully, an individual should have computer skills with intermediate to advanced abilities with the current Microsoft Office Suite as well as Windows applications. Must have electronic document management experience. Ability to quickly learn and use new software systems. Experience working in electronic source (esource) data platforms is desired.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; work in high, precarious places and fumes or airborne particles. The noise level in the work environment is usually quiet to moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk and stoop, kneel, crouch, or crawl.

The above job description does not imply these outlined duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

ProSciento reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and company.

ProSciento is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.