MAIN PURPOSE OF JOB
The Clinical Compliance role is responsible for the management and execution of activities associated with clinical procedural development and maintenance, clinical training programs, inspection preparedness, and assessment and investigation of clinical quality compliance issues. This position is also support management and execution of clinical vendor qualification assessments.
- Manage and oversee development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms and templates in compliance with global regulatory standards
- Execute strategy for role-based training curriculum, GCP training and Inspection Readiness training for the Clinical organization
- Ability to work with functional teams to flow out processes and develop previously unwritten work instructions and/or development of New SOPs
- Assistance with the preparation/collection of all training documents in preparation for internal training file audit (e.g. completed SOP matrices, CVs, JDs etc.)
- Oversee and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments
- Manage and oversee the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up and closure
- Manage the review of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.
- Execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections
- Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities
- Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
- Develops plans for internal and external audits ensuring compliance with all Food and Drug Administration, World Health Organization and Biological Licensing Agreements guidelines for regulatory standards as well as company policies/procedures.
- Directs and trains on Clinical Standard Operating Procedures and Clinical Operating Procedures to ensure compliance with regulatory organizations.
- Manages the clinical quality database of observations for quality analysis and assessment and identifies compliance risk.
- Organizes pre- and post-study document reviews and takes corrective action.
- Oversees technical document review and other good manufacturing practices activities in support of clinical development programs.
- Provides leadership in continuous improvement of good clinical practices.
- Partners with quality assurance management on good manufacturing practice requirements of drug product manufacture.
- Monitors audit reports to clinical management.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
- Establishes operational objectives and work plans and delegates assignments to subordinates. Senior management reviews objectives to determine success of operation. Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect.
- Plan, assign and direct work; manage, develop and support Clinical Compliance staff
- Manages activities of two or more sections or departments. Exercises supervision in terms of costs, methods, and staffing. In some instances this manager may have subordinate supervisors.
- Communication Proficiency.
- Time Management.
- Collaboration Skills.
- Personal Effectiveness/Credibility.
- Technical Capacity.
- Stress Management/Composure.
IMMUNOCORE VALUES – ALL STAFF
- We lead with science to benefit patients
- We are entrepreneurial
- We value diversity to drive innovation
- We respect each other and act with integrity
- We do the right thing
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
- Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
- Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers. Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
Experience & knowledge
- 8 years pharmaceutical industry experience with at least 5 years in compliance, quality, training or related clinical operations function.
- Prior experience with both clinical auditing and operations is required.
KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF
- Openness and honesty
Readily offering information pertaining to work in hand whether positive or negative.
- Taking responsibility
Being prepared to accept full responsibility for tasks entrusted to them; seeing tasks through to completion and dealing with the consequences of failure or success.
Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively. in a highly collaborative, multi-disciplinary team setting.
- Team spirit
Being able to work productively with others to achieve tasks. Showing consideration for the needs and feelings of others.
- Accomplishes goals under project timelines.
Preferred Experience & knowledge
Education & qualifications
- Bachelor degree in scientific/medical/pharmaceutical discipline or equivalent is required.
- 10+ years’ experience in related area with experience in QA/Audit setting or Additional Eligibility Qualifications
WORK AUTHORIZATION/SECURITY CLEARANCE (IF APPLICABLE)
Work authorization in the USA is required
Immunocore LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand as necessary.
POSITION TYPE AND EXPECTED HOURS OF WORK / TRAVEL
Office hours are weekdays during core business hours.
Some international and local travel maybe required for this position. Travel up to 20%