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Job Details

Therapeutic Area Clinical Quality Manager

Company: ClinTec International Ltd
Location:
Reference: ONC-CQM-270416-DH
Closing Date: 28 Dec 16
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

ClinTec International is actively recruiting for a number of Oncology Clinical Quality Managers to join our expanding global company in the US. These are permanent office based opportunities. By working for ClinTec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Requirements:

Oncology Clinical Quality Manager – PA/NJ,USA – Permanent opportunities!

ClinTec International is actively recruiting for a number of Oncology Clinical Quality Managers to join our expanding global company in the US. These are permanent office based opportunities. By working for ClinTec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

TA CQM: CORE Accountabilities and Responsibilities

Overarching Responsibilities:

  • Quality Management subject matter expert and primary point of contact for Clinical Therapeutic Area Heads to provide real-time, proactive advice and guidance on procedures and issues relating to Quality, Compliance and Global Processes related to clinical development program management, clinical trial activities and vendor oversight.
  • Ensures Quality Plans are implemented and executed (e.g. targeted QCV program) within Clinical Development Programs as prioritized according to the MRL Scorecard.
  • Link between Clinical Therapeutic Area Heads, GCTO, HQ CQM and MRL QA to facilitate appropriate issue escalation and resolution.

Audit and Inspection Support:

  • Oversees Story Boards for Clinical Development Programs and pivotal clinical trials to implement a risk based mitigation approach in view of inspection readiness.
  • Coordinates in collaboration with Global Inspections Lead (GIL) and/or Regional Inspections Lead (RIL), assignment of preparation support teams for trial-related sponsor and/or site inspections.
  • Supports the development of responses to internal audits and inspections and ensures appropriate CAPA implementation.
  • Ensures that all actions and commitments are implemented in a timely manner.

Quality Signal Detection:

  • Supports Therapeutic Area staff with in depth knowledge of current audit and inspection trends across and within programs.
  • Develop, implement and analyze TA specific holistic quality control plans (risk based approach) to detect quality signals before they are identified as audit observations and/or inspection findings.
  • Analyze and review QCV and audit results for outsourced trials to ensure adequate vendor oversight.
  • In close cooperation with Clinical TA Heads and their management team, discover areas for emerging compliance risks and initiate remediation and prevention activities.

Quality Signal Analysis:               

  • Provides processes, systems and knowledge needed to proactively disseminate known and potential quality issues from local/regional to global perspective.
  • Supports HQ CQM Management and Therapeutic Area staff by providing an ongoing consolidation and current overview of known issues.

Quality Issue Remediation:

  • Ensures that quality/compliance issues are addressed in accordance with all applicable change management processes.
  • Manages portfolio of global and regional quality initiatives emanating from both reactive (Audit, Inspection) and proactive sources.
  • Trends known quality issues, coordinates global and regional investigations.

Quality Issue Prevention:

  • Deploys and Maintains global Quality Information management tools (e.g. Story Boards) to track and trend issues as well as manage them through their implementation life-cycle.
  • Implements a Quality by Design approach from initial Protocol through Clinical Study Report.
  • Provides input and approves trial specific monitoring plans.
  • Provides input and approves CRO management plans for outsourced trials.
  • Supports qualification of global vendors.

TA CQM: OTHER Accountabilities and Responsibilities

  • Communication and Oversight: Collaborates with GCQM and HQ CQM staff (RCQM/ CCQM /CIL / GIL / RIL), Process Lead SMEs and GCTO Business Performance Management to create clinical quality management tools and procedures for conducting Clinical Trials at investigative sites worldwide.
  • Training: Actively collaborate with Continuous Improvement Leads (CIL) and MPI for the development and implementation of clinical quality management training programs for GCTO and TA staff.
  • Clinical Trial Process Improvement:  Collaborates with CIL and Process Lead SMEs to initiate global clinical trial process improvement projects and liaise with RCQM/CCQM for a successful execution of these projects.
  • CAPA management:  Coordinate/assist in responses to audit and inspection findings of GCTO clinical trial related activities.

Education: Bachelor’s Degree or equivalent in relevant health care area

Experience: 

  • A minimum of 10 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
  • Deep knowledge and understanding of Clinical Development Programs, Clinical Trial processes as well as quality management and control tools is required.
  • Experience in Therapeutic Area, specifically related to design of trials and therapeutic area specific clinical assessments and medical practice.
  • Direct experience in quality management, GCP Auditing and GCP Inspections. 
  • Experience delivering effective CAPA management solutions.

Skills: 

  • Superior oral and written communication skills in an international environment.
  • Excellent project management and organizational skills.
  • Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
  • Ability to leading cross-functional teams of business professionals.
  • Ability to analyze, interpret, and solve complex problems.
  • Ability to think strategically and objectively and with creativity and innovation.
  • Ability to proficiently interact with all levels of management and exert influence to achieve results.

Company Information:

ClinTec International is a UK-based, dynamic privately owned full service Contract Research Organisation with presence in over 40 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assist in their key product development efforts for over a decade. At ClinTec International, we pride ourselves on providing high quality, flexible and professional services and solutions to our clients. ClinTec International has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

ClinTec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnership with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. ClinTec International offers a competitive salary and rewards package.

Apply for this job:  Therapeutic Area Clinical Quality Manager

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
Glasgow
G3 8HB
Scotland
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

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