CRA/CSS Manager at GSK

Job Purpose

• The CRA/CSS Manager role within Global Monitoring and Site Engagement - Provides leadership, oversight and manages the activities of Clinical Research Associates (CRAs) and Clinical Support Specialists (CSS) to ensure the delivery of all clinical studies, across all therapy areas (Rx and Vx) to the required timelines and quality standards.
• Accountable to ensure the completion of all monitoring deliverables for all studies assigned to the LOC to agreed timelines, budget and quality standards. 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. Provides issue management and resolution and co-monitoring support for CRAs at sites to ensure productive, efficient study delivery.

Key Responsibilities

• Accountable to lead a team of CRAs and CSSs by providing study/GSK related training, coaching and mentoring for all staff. For internal staff this will include line and performance management; evaluating capabilities and competencies, identifying and coordinating implementation of personal development plans.
• Responsible for resource management and workload allocation so that studies are resourced appropriately and capabilities are aligned with study requirements, resource availability and business priorities. Responsible for recruitment and development of GSK permanent CRAs and CSSs.
• Responsibility to engage with the FSP partner and ensure they deliver according to agreed timelines and quality expectations.
• To ensure timely start up, operational management, completion and delivery of all Vx and Rx clinical studies across multiple therapeutic areas to agreed timelines, quality and budget.
• Ensures that critical study timelines related to CSS activities are achieved and that relevant cycle times, data and audit quality are met. Provides troubleshooting and problem resolution support for CSS to ensure productive, efficient contribution to study delivery. Responsible to manage clinical study activities according to GSK operating standards and good clinical practice.
• Effectively manages routine and complex issues and escalates appropriately.
• Assists with audits/inspections of local clinical operations department & study / sites in the country.
• Contributes to overall management of clinical research within the LOC via involvement in applicable leadership teams to ensure consistency and utilisation of resources and best practice.
• 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.
• In collaboration with Clinical Operation Head and Local/Regional Risk and Management Monitoring identifies management monitoring process checks linked with CRA and CSS activities that require inclusion in the local quality plan
• Responsible to identify and share best practices, standardizing across the LOC / region and representing local/regional clinical operations on global and cross functional initiatives. Represents study support on internal and cross functional process improvement teams.
• Collaborates and communicates on key operational issues with matrix partners at the local, regional and global level as required.
• 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.
• Available and willing to travel as job requires.

Other Skills

• This role requires working in a highly matrixed environment with internal and external customers based locally, regionally and globally. Customer service is a focus, as the role requires interaction with other GSK business areas e.g. central study teams, business system owners, LOC clinical staff and external stakeholders, investigators and site staff, vendors etc.
• Negotiation skills required both internally and externally to ensure maximum value from vendors across studies and/or programs. Represents GSK effectively with external organizations and/or has demonstrated effective presentation abilities to deliver key messages to audience members.
• Collaborative leadership style that proactively encourages empowerment with individuals/team to deliver the business objectives. Excellent people management skills including developing, mentoring and coaching others. Maintains enthusiasm, motivation and commitment to the team.
• Good networking skills with internal partners and contacts within other GSK business units to contribute to the design and successful delivery of studies/programs
• A variety of problems (simple and highly complex) can occur during a clinical study. You will recognize and react to changes that impact a study and/or program or practices and demonstrate a track record in quality decision-making and problem resolution. Contributing to solutions to manage study/program challenges and opportunities; suggesting new ways to apply existing knowledge.
• Confidence in working in an environment that is constantly evolving with new processes, tools and systems, internally and externally. Understands and effectively utilizes change management tools and approaches.

Minimum Level Of Education Required
Knowledge/Education Required

• Bachelors degree or equivalent

Area of Specialization

• Any general science degree e.g. life science, medicine, clinical research, pharmacy etc.

Basic Qualifications/Experience

• A minimum of 5 years’ experience in clinical operations is required with a preference of 2 years of line management experience. Profound 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.
• Good understanding of and experience in project management. Knowledge or ability to acquire expertise regarding use of multiple systems / tools related to clinical studies.
• Stakeholder management skills required as the role includes interactions with senior stakeholders at a central or LOC level.
• Strong written and verbal communications skills are required in English and local language.
• Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment.
• 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.

Preferred Level Of Education

• Masters or equivalent