QuintilesIMS Director, CPM - Real World Late Phase (Home or Office-based) in Cambridge, Massachusetts
IQVIA™ Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers and patients. Our approach is unique in the industry and is defining the way companies can develop and apply real-world evidence to provide deeper insight about market dynamics, therapy area changes, outcomes research and other scientific insights. We are collaborative, intellectually curious, entrepreneurial and constantly looking for opportunities to harness the value of real-world evidence in a constantly evolving industry.
We are looking for candidates with:
• Proven track record delivering observational studies
• a strong understanding of secondary data sources and how these can be applied to provide novel solutions in the collection and analysis of real world data
• practical knowledge of Direct to patient strategies and patient centered outcomes
• Knowledge of wearable/digital technology to collect patient data directly
• A background in early client engagement and proposal development
Direct and manage an assigned team of clinical project management staff who manage or support studies or programs 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.
• 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 and programs.
• 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 appropriate development plans.
• Proactively manage risks linked to resourcing, project and/or individual needs with other management and leadership team members to manage study issues and obstacles.
• Act as a key relationship manager for assigned clients; recommend courses of action regarding client management issues; ensure that plans are implemented following approval by senior management.
• 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.
• 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.
• Provide consultation to clients on drug development process, strategy, and plans as needed.
• Participate in function and/or corporate initiatives, special project assignments, and as a client liaison or departmental cross-functional liaison.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
• Proposal development and successful Bid Defense experience
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Excellent communication and interpersonal skills, including good command of English language
• Excellent organizational and problem solving skills
• Effective team-management skills
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
• Effective mentoring and training skills
• Ability to balance operational and strategic priorities
• Excellent customer service skills
• Good judgment and decision making skills
• Good understanding of other Quintiles functions and their inter- relationship with Clinical Project Management
• Strong software and computer skills, including MS Office applications
• In depth technical and/or therapeutic expertise and knowledge of study, project and drug development processes
• Knowledge of project financial tracking and accounting methods and skill in applying them
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
Bachelor's degree in life sciences or related field and 12 years’ clinical research experience including 8 years’ leadership experience, including multi-regional and global focus; or equivalent combination of education, training and experience.
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