Roles and Responsibilities

The Manager Clinical QA will be responsible for:

• Conducting Good Clinical Practices (GCP) Risk Assessments.
• Assisting in the development and implementation of the annual QA-GCP audit plan using a risk-based approach.
• Preparing with line functions and QA management in the development of corrective action plans.
• Analyzing and reporting trends in audit findings, as requested.
• Reviewing and assessing key metrics (i.e., quality of TMF structure, risks, time for project, etc.).
• Participating in program and protocol team meetings as the QA Representative.
• Maintaining knowledge on industry leading practices and current regulations surrounding GCP compliance.
• Participating in regulatory inspection activities for sponsor and sites.
• Develop, direct and implement Quality Systems/Programs to ensure compliance to company standards, Industry standards and Regulatory Requirements.
• Ensure that Clinical studies are conducted in compliance with study protocols, GCP, GLP and federal guidelines.
• Manage the SOP Process including the identification, development, approval, implementation, periodic review, revisions, controls and archival of all SOPs.
• Stay updated with Quality Assurance and regulatory trends, develop and implement recommendations regarding actions necessary to assure ongoing compliance.
• Provide guidance and training to the investigator sites /Clinic team as when required.
• Perform all activities in compliance with company SOPs, safety standards, study protocols, GCP and regulatory requirements.
• Participate and assist with regulatory inspections.

Qualifications and Background Requirements

• BA/BS degree within a scientific discipline.
• Bachelor’s degree (or equivalent) in medicine, pharmacy, life science, or any other relevant field.
• Minimum 5 years’ experience in clinical trials /GCP auditing (preferably 3 years in GCP Auditing).
• Complete knowledge of GCP standards and regulations.
• Strong observational, analytical, and communication (written and verbal) skills.
• Collaborative skills and ability to work independently.

Professional Work Experience

• A minimum of 5-8 years in the Pharmaceutical/Biotechnology industry is required with at least 2 to 4 years of independent GCP auditing experience preferably in relation to sponsor, site, central lab and vendor audits required.
• Experience in clinical operations and handling trial essential documents is required.
• Strong knowledge of global regulatory requirements for clinical trials and ICH/GCP guidelines.
• Working independently to complete assigned tasks.
• Solid written and verbal communication skills, analytical and problem solving skills.
• Flexible, highly motivated, with strong organization skills and the ability to multitask.
• Proficient Computer Skills: Specifically MS Word, MS Excel, MS PowerPoint.

Roles and Responsibilities

Clinical Quality Assurance Auditor will be responsible for:

• Schedule, prepare, conducts and reports assigned audits of the Client’s projects and operational processes in accordance with approved procedures, schedules and formats.  Audits include Investigative Sites, Clinical Vendors, Clinical Study Reports and Trial Master Files. 
• Provide clear, accurate and concise advice on GCP and compliance related questions from Operational teams.
• Must have in-depth knowledge of ICH GCP and FDA and EMA regulations and guidance.
• Write and issue audit reports in accordance with standard Company formats and timelines, ensuring clear communication of audit findings to the relevant project team members and/or functional area management.
• Review responses to audit findings for appropriateness and completeness. Follow up as appropriate to obtain audit response.
• Maintain accurate and timely documentation of QA auditing activities.
• Serve as Lead Auditor for project audits as required.
• Coordinate and conduct internal audits (project, process).
• Create, maintain and revise departmental standard operating procedures, forms and templates.
• Work with clients/sponsors when required.
• Serve as a trainer and mentor to less experienced QA Auditors.
• Manage assigned quality issues in accordance with Company requirements.
• May be required to host Sponsor audits and assist in Regulatory Inspections.

Qualifications and Background Requirements

• Bachelor’s degree (or equivalent) in medicine, pharmacy, life science, or any other relevant field.
• 3-5 years’ experience in clinical trials /GCP auditing (preferably 3 years in GCP Auditing).
• Complete knowledge and application of GCP standards and regulations.
• Strong observational, analytical, and communication (written and verbal) skills.
• Collaborative skills and ability to work independently.
• Experience in conducting GCP, compliance and process audits;
• Experience in conducting all audit areas, Investigator Sites, Vendors, Data Management, Biostatistics, Safety Management, Trial Master File etc.
• Ability to travel up to 30%-40% of the time. 

The Clinical Project Manager is responsible for project management expertise for clinical trials.

• Create and oversee project timelines and budgets, manage competing timelines and prioritize critical tasks.
• Contribute to the creation and review of essential trial documents such as protocols, informed consents, case report forms, clinical study materials and monitoring tools.
• Ensure appropriate versioning and translations of documents.
• Schedule and lead trial team meetings throughout the life of the trial.
• Maintain trial level tracking, including enrollment, trial status, and SAE reporting.
• Lead, support, and guide trial team members to ensure trial delivery on time, on budget and with appropriate quality. Track budget and timeline against plan.
• Evaluate, select, negotiate, contract and manage service providers (e.g. CROs, consultants).
• Planning and execution of trial level site relations, including site identification, selection, investigator meetings, and newsletters. Ensure proper paperwork is completed and filed for investigative sites to participate in clinical trials.
• Coordinate with finance department for site payments.
• Work with other departments to ensure timelines are met and that all projects are performed in accordance with internal and external regulatory and compliance processes.
• Conduct contingency planning, identify short and long-term project issues, and provide suggested solutions to management.
• Create SOPs as needed.
• Work effectively as a team player within Clinical.

Education and Experience

• Bachelors degree in health related field
• Minimum of 5 years experience in clinical research (Phases I through IV) in CRO, pharmaceutical or biotechnology environment
• Sufficient knowledge of clinical trials process to allow best use of resources and planning
• Proven experience in project management for clinical trial activities
• Forecasting and budgeting experience
• Strong attention to details and solid follow through.
• Ability to complete deliverables on time and adjust priorities in a fast paced environment

The Clinical Trial Manager is responsible for the day to day operation of a given clinical study. Responsibilities include:

• The development of clinical protocols, Investigator’s Brochures, information/consent forms, training material, case report forms, diary cards, clinical study reports and other clinical documents, as required by the project.
• Participation in writing clinical sections in regulatory documents (e.g., BLA or IND).
• Manage internal Clinical Research Associates and provide guidance for their overall professional development.
• Define project specifications, assisting with the evaluation of potential providers, and monitoring progress on an ongoing basis.
• Manage study timelines. Reports on study progress and provides options for handling problems that develop. Appraises line managers of situations as they arise and provides progress updates/summaries as required.
• Ensure that all tasks that contribute to the conduct of a clinical study are completed on time and within budget.
• Provide input into protocols, case report forms, data management plans, clinical study reports, and regulatory filings.
• Design and review informed consent forms and other study related documents in compliance with ICH CGP guidelines.
• Maintain paper and electronic filing systems and tracking systems.

Requirements:

• A BS and/or MS in life sciences or healthcare discipline with 3-5 years of hands-on clinical operations experience in the biotech/pharmaceutical industry is required.
• Additional experience in site monitoring and overseeing CRA’s is required.
• Knowledge of good clinical practice (GCP) and FDA and ICH regulations and guidelines.
• Good understanding of cross functional areas including data management, medical writing, and biostatistics.