CRA Manager

Waltham, Massachusetts
Feb 12, 2021
May 07, 2021
Jobseeker Type
Organization Type
CRA Manager

Global Clinical Operations is transforming to fulfil our vision to “Be the best performing and trusted Global Clinical Operations organization”. Our mission is to “Accelerate the pipeline through innovative, efficient and expeditious delivery of high-quality data”.

We are looking to recruit a number of CRA Managers - Provides leadership, oversight and manages the activities of Clinical Research Associates (CRAs) to ensure the delivery of all clinical studies, across all therapy areas (Rx and Vx) to the required quality standards, GSK written standards and ICH GCP.

This role will provide you the opportunity to lead key activities to progress your career.

Job purpose and key responsibilities:

  • Accountable to lead a team of CRAs by providing study related training, coaching and mentoring for all staff and in addition, line and performance management for internal staff.
  • Responsible for effectively managing capacity utilization of internal and insourced CRAs / SCRAs, ensuring alignment of capabilities with study requirements, resource availability and business priorities. Contribute to overall management of clinical research within the LOC via involvement in applicable leadership teams to ensure consistency and utilization of resources and best practice.
  • Responsibility to engage with the FSP partner and ensure they deliver according to agreed timelines and quality expectations.
  • Accountable to ensure the completion of all monitoring deliverables for all studies assigned to the LOC to agreed timelines, budget and quality standards. The CRA manager works with the CRAs / SCRAs to resolve and escalate issues that may impact study delivery.
  • Responsible to identify and share best practices, standardizing across the LOC / region and representing local/regional clinical operations on global and cross functional initiatives.
  • Recruitment and development of GSK permanent CRAs. Responsible for oversight of GSK and insourced CRAs.
  • Collaborates with the relevant country and/or central teams for determining the feasibility of conducting protocols with reference to patient population, study complexity, and relevant resource. Maintains oversight of selection of suitable hospitals/clinics/investigators.
  • Ensures that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met for both GSK and insourced CRAs. Provides issue management and resolution and co-monitoring support for CRAs at sites to ensure productive, efficient study delivery.
  • Ensures the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities.
  • In collaboration with Clinical Operation Head and Local/Regional Risk and Management Monitoring identifies management monitoring process checks linked with CRA activities that require inclusion in the local quality plan.
  • Evaluates capabilities and competencies of internal staff, identify and coordinate implementation of personal development plans for direct report
  • Assists with audits/inspections of local clinical operations department & study / sites in the country.
  • Continuous development of knowledge in the areas of GCP, internal company guidelines, SOPs , new monitoring technologies and capabilities Serves as an expert in ICH GCP and GSK written standards for internal and insourced CRAs.
  • Available and willing to travel as job requires.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Bachelor's degree or general science degree e.g. life science, medicine, clinical research, pharmacy etc.

  • Bachelor's degree or general science degree e.g. life science, medicine, clinical research, pharmacy etc.
  • 5+ years' experience in clinical operations
  • 3+ years of operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug/vaccine development process.
  • 3+ years' experience with use of project management. Knowledge or ability to acquire expertise regarding use of multiple systems / tools related to clinical studies.
  • 3 + years of Stakeholder management skills required as the role includes interactions with senior stakeholders at a central or LOC level.
  • 3+ years of planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment. Works in an environment that is constantly evolving with new processes and systems, internally and externally and the CRA manager needs to be able to adapt to these changes quickly and efficiently.

Preferred Qualifications:
  • Master of Science
  • 2 years of line management experience.
  • Demonstrates track record in quality decision-making and problem resolution that impacts study/program direction. Recognizing potential risks and can implement effective mitigation strategies.
  • Recognizes and reacts to changes that impact a study and/or program or practices, and has the skill set to assess the appropriateness of protocol/plans in the local environment.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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