IQVIA Senior Director, Project Management, Internal Medicine (Home-Based) - IQVIA Biotech in Englewood, Colorado
POSITION TITLE: Senior Director, Project Management, Internal Medicine
REPORTS TO: Executive Vice President/ Vice President, Project Management or Designee
To provide strategic leadership, organization, training, and ongoing evaluation and support to the Clinical Operations group. To assure growth of revenue and profitability through the provision of quality, client-oriented, clinical operations services. To develop and assure compliance to departmental standards of excellence and compliance with departmental financial targets. To assure compliance with (1) IQVIA Biotech standard operating procedures (SOP), (2) GCP and ICH guidelines, (3) all applicable national and international regulations, and (4) company, client and departmental standards and expectations.
Leads business development efforts surrounding proposal generation, defense and award. Key role in the development of client proposals including both costs and textual support.
Provides support in client negotiations, internal process implementation, and trend analyses. Supports the department director in development of functional training, definition of standards, and employee evaluation.
Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement.
Manages Project Management (PM) staff having responsibility for performance and proficiency at the staff and project level. Provides support in client negotiations, internal process implementation, and trend analyses. Supports the department director in development of functional training, definition of standards, and employee evaluation.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Responsible for strategic direction of the assigned division.
Responsible for divisional billability, divisional project financial performance, staff development, developing and implementing strategic priorities, leading proposals and acting as Executive oversight for assigned clients.
Responsible for the direction and the performance of the Project Management staff as assigned. Works with the leadership team in Project Management (assigned division), to develop departmental strategic goals and divisional goals in concert with corporate goals, and then formalize departmental action plans to meet those goals. Provides guidance to staff, as needed, for completion of goals.
Assure divisional compliance with SOPs, CAPA completion and defined departmental metrics.
Provides required and supplemental training to staff. Provides ongoing feedback regarding staff performance and assesses performance at least annually with quarterly documented review of goals. Makes recommendations regarding salary adjustments.
Assures compliance with Good Clinical Practices (GCP) within all Clinical Program Services (CPS) functional areas.
In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms.
Responsible for identifying processes which need updating and documenting that to the divisional lead.
Assists in developing budgets and is accountable for the profit/loss for the Project Management component of each project and the overall performance of the PM department.
Responsible for building and maintaining positive client relationships
Ability to negotiate with clients to assure IQVIA Biotech’s operational processes are maintained, projects are done within scope, and team members do not initiate in activities based on client request and not best practices
May be assigned to project work. If assigned responsible for all project Deliverables including:
Reviewing and identifying project study trends and proactively responding to client and respective team members
Developing appropriate early warning systems of impending obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges
Identifying, define, document in LMS systems and assure project level compliance with study specific training requirements
Responsible for change management on all assigned projects
Supports Project Management staff in the management of individual project operational management with appropriate escalating to department heads, VP Level Management or Executive Oversight as escalation is necessary. Success will be defined by strong management of project operations for those projects within the Director’s reporting structure. Director should demonstrate not just corrective action, but staff mentoring to drive both project success and staff development.
Supports Associate Directors in developing operational strategies to assure successful implementation/execution of every contracted study. Interacts with all levels of management regarding IQVIA Biotech’s operational processes to assure operationally effective and financially efficient implementation.
Assures reporting line has project level plans and strategies in place to assure proactive study management.
Assures direct line has implemented appropriate early warning systems of impending obstacles to the successful completion of the projects; analyzes or supports the analysis of information and develops/supports line development of innovative solutions to challenges
Supports Project Management staff in the management of individual project budgets assuring fiscally responsible management with appropriate reporting to VP level Management. Success will be defined by tight management of project finances for those projects within the Director’s reporting structure.
Oversees IQVIA Biotech and external organizations’ project interactions. Supports IQVIA Biotech in the management of any operational vendor relationships as necessary.
Maintains current knowledge of local regulations, and ICH GCP Guidelines for clinical research. Participates in business development activities as required to support ongoing growth of IQVIA Biotech.
Responsible to maintain personal currency documentation for IQVIA Biotech SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at every instance of out of office Ability to independently resolve 95% of all client or team issues at a high complexity rating
Responsible to maintain direct line currency with for IQVIA Biotech SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at every instance of out of office
Conduct performance appraisals of all direct reports
Administratively approve timesheets for all staff
Approve project direct and pass-thru expenditures up to:
Other expenses to $10,000
Other expenses to £5000.00
Hold client deliverables when deemed appropriate for financial or quality reasons
Approve IQVIA Biotech client proposals for all reporting functional areas
KNOWLEDGE, SKILLS AND ABILITIES:
Experience in managing global operational teams
Experience in the assigned divisional therapeutic or demonstrated expertise
Strong leadership skills including financial management, problem solving, employee development and negotiation
Knowledge of clinical research process from Phase I through regulatory submission
Strong communication skills (verbal and written) to express complex ideas
Excellent organizational and interpersonal skills
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
Ability to manage multiple priorities
Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings
Ability to set baseline targets, track trends and implement mitigation plans
Demonstrated knowledge of electronic data management and clinical operations
Demonstrated knowledge of quality assurance related to clinical trial implementation
Demonstrated ability to form strong working relationships across functional boundaries
Demonstrated ability to motivate, lead, and grow a project management team
Extensive demonstrated experience directing a project management team
Extensive experience with monitoring and/or data management supervision according to Good Clinical Practice
Experience with pharmaceutical and/or device product development
Excellent knowledge of regulatory and ICH GCP guidelines for conducting clinical research
Excellent written and verbal communication skills including presentation skills and negotiation skills
Exceptional ability to conceptualize, develop and manage process solutions
Demonstrated knowledge of financial management
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very limited physical effort required to perform normal job duties.
MINIMUM RECRUITMENT STANDARDS:
Previous Management Requirements:
Nursing or University degree (US Bachelor level or equivalent) in a health-related field or advanced business degree (6 year or equivalent) with at least eight (8) years of demonstrated clinical trials management experience OR Appropriate clinical experience with ten (10) years of clinical trials management experience
And, within the total years of experience, at least six (6) years of management experience in a contract clinical research position is required.
At least 2 years of experience at the Director Level
Experience in clinical monitoring and/or data management is required. Experience in electronic data management is required.
Excellent demonstrated knowledge of issues affecting data analysis for clinical trials required.
Excellent written and verbal communication and presentation skills required.
Ability and willingness to travel nationally and internationally as required.
US: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
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