Associate Director/Line Manager, Clinical Project Management
Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking Associate Director/Line Manager, Clinical Project Management to work with our Cardiovascular and Metabolic Therapeutic Delivery Unit.
The Associate Director/Line Manager will supervise and manage an assigned team of clinical project management staff who manage or support studies to ensure quality, time and budget deliverables are met to the Sponsor's satisfaction. Work with staff to ensure that all study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. Ensure that employees are trained and individual development is aligned and in place to meet project and organizational needs.
RESPONSIBILITIES
- Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
- Actively provide guidance and review of the scope of work, objectives, timelines, quality of deliverables, and other clinical project management activities for studies.
Coach and mentor employees around project planning, project review, risk management and problem solving to ensure global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees. - Work with the clinical project managers to ensure that project budget(s) meet financial and company goals (realization targets), with a focus on proactively ensuring adherence to change control processes.
- Obtain and provide regular feedback to employees from other clinical project team members and key stakeholders to assist in personal and professional development. May attend project team meeting and site visits in order to support development needs. Identify skill and competency gaps at the individual level and work to craft development plans that will close the gaps
- Working with individual staff to identify any quality issues within the study and coaching on resolution of issues, including implementation of corrective action plans and escalation.
Collaborate with other management and leadership team members to proactively identify project and or individual needs and resourcing solutions in order to manage study issues and obstacles. - May act as point of contact or oversight for specific customers or programs.
- Provide technical expertise and clinical project management experience to project management and training and process improvement efforts.
- Serve as a project management liaison with other groups within Quintiles.
- Participate in function and/or corporate initiatives, special project assignments, and as a client liaison or departmental cross-functional liaison.
Bachelor's degree in life sciences or related field and 10 years' clinical research experience including 6 years' project management/leadership experience; or equivalent combination of education, training and experience.
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Excellent organizational and problem solving skills
- Demonstrated management skills
- Good team leadership skills
- Effective mentoring and training skills
- Excellent customer service skills
- Ability to manage competing priorities
- Strong software and computer skills, including MS Office applications
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
