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
PURPOSE
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.
Responsibilities
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).
PERFORMANCE METRICS
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
KEY DELIVERABLES
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
Primary Location
South Africa
Other Locations
Namibia, Nigeria, Ghana, Tanzania, Benin, Mali, Mozambique, Tunisia, Zimbabwe, Uganda, Kenya, Botswana, Angola, Burundi
Organization
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
KEY COMPETENCIES
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.
Functional: Essential
Leading & Directing
Deciding & Initiating Action
Planning & Organizing
Influencing Others with Impact *
Adapting & Responding to Change
Functional: Desired
Analyzing
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.
PHYSICAL REQUIREMENTS
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
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