Clinical Quality Manager

Updated: December 7, 2018
Location: Raleigh, NC, United States
Job ID: 2250

Overview

You’re driven, resourceful, and above all else – remarkably smart.
You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.

Here, there’s no shortage of challenging work, learning and opportunities. Because we offer many services to varied clients, our knowledgeable professionals gain experience across a large section of the industry. Our client roster consists of more than 550 organizations including all 20 of the largest global biopharmaceutical companies.

Responsibilities

This opportunity is with Syneos Health Consulting, an industry-leading consulting firm specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. You’ll join a team with industry focus, depth of functional expertise, and strong scientific and market knowledge that is uniquely positioned to tackle highly complex business and market challenges to develop achievable strategies for our clients.

We are currently recruiting for a Clinical Quality Manager to join our team. The Clinical Quality Manager will work with project teams supporting Syneos Health's biotech and pharma clients.

Job Requirements

Under the guidance of HQ CQM Lead, the HQ CQM Contractor will oversee clinical quality management within the Therapeutic Area supporting Clinical Trial Teams to proactively embed quality into sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.

The candidate will be responsible for the development of Quality Plans to implement Quality by Design within Clinical Development Programs, using a risk based approach and collaborating with Clinical Trial Teams in implementing and executing Quality Control activities.)

 HQ CQM: CORE Accountabilities and Responsibilities

 Overarching Responsibilities:

  • Provides 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.
  • Supports Clinical Trial Teams in performing risk assessments, completing the RACT (Risk Assessment Categorization Tool), developing Quality Plans; and performing quality data review for Clinical Development Programs.
  • Collaborates with HQ CQM Lead to facilitate appropriate quality issue escalation and resolution in accordance with all applicable change management processes. Quality Issue Prevention:
  • Implements a Quality by Design approach from initial Protocol through Clinical Study Report.

Provides input and approves trial specific monitoring plans.

Supports qualification and quality management of global vendors.

Supports Clinical Trial Teams to ensure state of inspection readiness throughout the course of a trial.

Audit and Inspection Support:

  • Supports Clinical Trial teams in the development of Story Boards throughout the course of a program/protocol in support of inspection readiness.
  • Supports the Global Inspections Management group, as part of the preparation support teams for trial-related sponsor and/or site related inspections.
  • Supports the development of responses to sponsor/trial level audit and/or inspection findings and ensures appropriate and timely CAPA implementation.

Quality Signal Detection:

     Develops and manages targeted QCV process, including the analysis and development of appropriate action plans in agreement with defined thresholds.

     Develops and manages Quality Plan throughout the course of a trial.

Education: Bachelor Degree or equivalent in relevant health care area

Experience:

A minimum of 5 years of relevant experience in clinical research

Knowledge and understanding of Clinical Development Programs, Clinical Trial processes as well as quality management and control tools.

Experience in design of Clinical Trials, Clinical Trial Operations, therapeutic area specific clinical assessments and/or medical practice is preferred.

Direct experience in quality management, GCP Auditing and GCP Inspections is an asset.

Experience delivering effective CAPA management solutions is an asset.

Skills

Superior oral and written communication skills in an international environment.

Project management and organizational skills.

Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.

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.

Location:

Flexible (East Coast or Central or Remote)

Remote candidates should be flexible to come to the office for 1 – 2 weeks for onboarding

Remote candidates should be flexible to come to the office in the event of a Sponsor Inspection for the project they are assigned

Remote candidates should be flexible to come to office in the event of an important face-to-face meeting (infrequent)

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