IQVIA Associate Director, Project Management (General Medicine, Home-based) - Novella Clinical in Denver, Colorado
Novella Clinical is looking for an experienced Associate Director, Project Management to join our growing team. Clinical Research experience in a CRO required. Experience with a variety of therapeutics required.
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) Novella 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, 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 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 appropriate transition of staff both into Novella and into new roles in the department securing transition documentation and assuring LMS documentation of all training at the departmental level.
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.
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 Novella’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 Project Managers in developing operational strategies to assure successful implementation/execution of every contracted study. Interacts with all levels of management regarding Novella’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.
Responsible for the direction and the performance of the Project Management staff as assigned. Measures of success will include the success of those staff and the associated projects within the Managers reporting structure.
Oversees Novella and external organizations’ project interactions. Supports Novella in the management of any operational vendor relationships as necessary.
Maintains current knowledge of local regulatory regulations, and ICH GCP Guidelines for clinical research. Participates in business development activities as required to support ongoing growth of Novella.
Ability to independently resolve 95% of all client or team issues at a high complexity rating. (Specifically anticipated to include client facing and financial issues although this may vary)
Responsible to maintain personal currency documentation for Novella SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at each and every instance of out of office
Conduct performance appraisals of all direct reports
Administratively approve timesheets for all direct line staff
Approve project direct and pass-thru expenditures up to:
KNOWLEDGE, SKILLS AND ABILITIES:
Demonstrated knowledge of electronic data management 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, medical device, or in-vitro diagnostic product development
Excellent knowledge of regulatory and/or 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.
Must be able to secure a credit card cosigned by Novella
Must be able to travel up to 30%, will include international travel
MINIMUM RECRUITMENT STANDARDS:
Nursing or University degree (US Bachelor Level or equivalent) in a health-related field OR advanced business degree (or equivalent) with at least eight (8) years of demonstrated clinical trials management experience OR minimum 4 year degree with appropriate clinical experience and eight (8) years of clinical trials management experience.
Within the total years of experience, at least four (4) years of management experience in a contract clinical research position is required.
Experience in clinical monitoring and 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 presentation and communication skills required.
Ability and willingness to travel nationally and internationally as required.
Exceptional ability to conceptualize, develop and manage process solutions and work with clients in all phases or research programs
Demonstrated negotiation skills
EEO Minorities/Females/Protected Veterans/Disabled
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