Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.
Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com
JOB TITLE: Clinical Lead, home or office based in Africa-1505918
Member of the core project team and partners with the Project Leader to ensure overall project meets delivery requirements. Responsible for running large studies, with Lead Clinical Analyst (LCA) support, and manage the operational aspects of projects to meet contractual requirements and in accordance with SOPs, policies and practices. Represent clinical delivery with customer.
Accountable for right subjects and right data to meet all contractual requirements. Collaborate with project leader and LCA to establish an integrated set of plans and be ultimately accountable for results of the clinical team.
Represent clinical delivery with customer.
Produce and distribute status reports for the core project team, other functional groups and senior management.
Ensure appropriate subject recruitment plans are in place; all outreach or digital offerings are explored and deployed in consultation with the customer. Ensure the Site Recruitment Action Plan (SRAP), patient recruitment target and contingency plans are in place and deployed at trigger points.
Deliver the project / program according to the quality management plan. Guide CRAs and advise on critical specific study issues
Manage clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management and project management forums
Accountable for approving final sites lists.
Member of the core project team working with the Project Leader to ensure overall project delivery.
Develop the risk management plan from a clinical perspective and proactively coordinate clinical issue escalation and resolution with the Project Leader.
Collaborate with other functional groups such as Global Delivery Network (GDN), Labs, Data Management, Pharmacovigilence, and Biostatistics, where necessary, to support milestone achievement and to manage study issues and obstacles.
Provide ongoing training and support to the clinical team. Conduct team meetings and ensure regular communication.
Drive high performance and efficiency of the clinical team through CRA project objectives and the conduct of monitoring visits. Provide performance feedback to management on clinical team members.
Collaborates with the Site Network Manager and the CRA Resource Manager on CRA development.
Participate in proposal development and sales/proposal presentations.
May mentor and coach new peers as they assimilate into this role.
Attend site visits as applicable in support of project delivery
All responsibilities are essential job functions unless noted as nonessential (N).
Proactive achievement of overall recruitment target for the study
Deliver the right sites, e.g. % non-enrollers, per study strategy
Manage Site Network utilization
Meet quality standards (to be determined) & study milestones
Meet CL project financial targets
Feedback from core project team
Customer satisfaction scores
Full compliance with the new alerts framework
Serves as a core project team member; leads and mentors the clinical operations sub team to support their professional development
Deliver study quality and patient recruitment per agreed specifications and drives site compliance
Clinical team training
Accountable for the study’s site ID and selection process (review SIFs, select sites for SSV)
Sites activated on / ahead of time to meet agreed customer expectations for assigned projects
Namibia, Nigeria, Ghana, Tanzania, Benin, Mali, Mozambique, Tunisia, Zimbabwe, Uganda, Kenya, Botswana, Angola, Burundi
ZAF02 – South Africa – CDS/Product Dev
Required Knowledge, Skills And Abilities
Strong knowledge of Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
Proven ability to understand customer needs and appropriately influence decision making
Effective mentoring and training skills
Ability to balance operational and strategic priorities
Strong communication skills
Demonstrated proficiency in using systems and technology to achieve work objectives
Demonstrated proficiency at analyzing data and information to make conclusions and drive sound decision making
Quintiles Leadership Competencies
Customer Centricity: Assesses customer experience and makes recommendations to improve it (e.g., identifies breakdowns in internal processes and systems that directly impact customer service and retention). Effectively manages customer’s needs by probing deeper to more fully understand what’s going on with their business and how that impacts their relationship with Quintiles.
Business Acumen: Solves challenging problems balancing facts and logic, experience and commonsense. Embraces necessary change and is able to change one’s own behavioral style as appropriate to the situation. Thinks through customer issues and raises questions (e.g., to clients or internally colleagues) to help determine solutions or makes things better for customers. Has curiosity about the drivers of our business (e.g., does continuous research on the industry, marketplace and competition, and keeps abreast of market trends and developments. During times of ambiguity and stress, is able to demonstrate a controlled demeanor, remain productive and stay focused on business priorities
Influencing Others with Impact *: Establishes credibility and confidence, while avoiding misunderstanding and enhancing relationships. Is an effective communicator who maintains a disciplined approach to accurate communications, within reasonable timeframes, focus and respect for the particular audience. Able to communicate effectively through different media, utilizing technology, including social media, Demonstrates interpersonal diplomacy in communications and influencing uses straightforward information (e.g., data or facts) as a means of direct influence during a discussion or presentation.
Collaboration: Actively engages in cross-business/function/region collaboration, working effectively across the matrix to achieve best in class solutions. Shares information and own expertise with others to enable them to accomplish group goals. Listens, assimilates and responds to different points of view during discussions with partners. Builds strong personal internal and external partnerships and networks that offer competitive advantage
Global Citizenship & Social Responsibility: Firmly believes in Quintile’s mission of bringing people and knowledge together for a healthier world. Demonstrates social responsibility by acting with highest standards of integrity and ethics. Demonstrates cultural awareness, showing respect for cultural diversity in all communication and interaction with co-workers and customers. Is socially aware and actively participates in social and community responsibilities.
Leading & Directing
Deciding & Initiating Action
Planning & Organizing
Influencing Others with Impact *
Adapting & Responding to Change
Applying Expertise & Technology
Achieving Personal Work Goals & Objectives
Presenting & Communicating
Coping with Pressures & Setbacks (focus on demonstrating resilience)
Minimum Required Education And Experience
Bachelor’s degree in a health care or other scientific discipline with 7 years clinical research/monitoring experience; or equivalent combination of education, training and experience.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Occasional travel may be required
How to Apply
Interested and qualified candidates should Click Here to Apply