IQVIA Commercial GmbH & Co. OHG
Clinical Project Director, Oncology, Late Phase (EU, Home-Based) - IQVIA Biotech
Publiziert am: 10/10/21 | Stevenage | VollzeitJetzt bewerben
Manages projects of full scope regional and global programs. Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the duration of each clinical trial. Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by IQVIA Biotech and sponsors. Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement
Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement.
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.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Manages projects of full scope regional and global programs. Responsible for project team leadership. May operationally oversee the work of other project management staff.
- Responsible for building and maintaining positive client relationships and keeping all project reporting current and assuring executive management is aware of issues putting IQVIA Biotech at financial or regulatory risk through the approved upon pathways for reporting.
- Ability to negotiate with clients to assure IQVIA Biotech’s operational processes are maintained and projects are done within scope.
- Reviewing and identifying project study trends and proactively responding to client and respective team members.
- Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges.
- Identify, define, document in requirements in LMS systems and assure project level compliance with study specific training requirements.
- Responsible for change management on all assigned projects.
- Ability to independently resolve project related issues.
- Responsible for assuring projects assigned are run according to SOPs and WP as defined in the contract.
- Responsible for assuring project timelines are met as per contract.
- Responsible for identifying study processes which need to be created or updating and documenting that to the direct line manager or divisional lead.
- Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware of issues putting IQVIA Biotech at financial or regulatory risk through the approved upon pathways for reporting
- 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.
- Assists in communication of budget allocations and approval of invoices.
- Provide other project support to Managers, as assigned.
- Oversee delegation of support staff activities, as necessary.
- 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.
- Responsible for identifying processes which need updating and documenting that to the divisional lead.
- Leads the development and delivery of capability and proposal defense presentations to prospective clients. Takes a cross functional leadership role in assuring client presentations are effective
- Ability to present personal skills and IQVIA Biotech capabilities in any client presentation resulting in work awards.
- Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team. Represents senior management in negotiation of contracts as appropriate.
- Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually
- Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
- 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. In addition, responsible to assure currency for those within the Program Director’s reporting line
- Performs other duties as required.
- Authorized to:
- Negotiate deliverable timelines with clients leading to contract amendments
- Negotiate scope of work agreement with clients as per company policy
- Approve project direct and pass-thru expenditure as per company policy
- Responsible for all activities related to implementation of clinical studies, when responsible for project management, including:
- Project team leadership
- Communicating and documenting interactions with clients based on SOPs
- Defining and implementing functional standards, goals, and expectations
- Assuring thorough planning and effective implementation of trials based on contracted scope of work, project timelines, and milestones
- Managing ongoing team activity
- Reviewing project budgets, monitoring costs, potential overruns and implementing cost effective solutions
- Reviewing and identifying project study trends and proactively responding to client and respective team members at least annually
- Developing appropriate early warning systems of impending obstacles to the successful completion of the project, analyzes information and develops innovative solutions to challenges
KNOWLEDGE, SKILLS AND ABILITIES:
- Knowledge of clinical research process
- 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 within various clinical trials
- 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 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 and lead a project management team.
- Demonstrated financial and operational management, negotiation and problem-solving skills.
- Extensive experience with monitoring and/or data management supervision according to Good Clinical Practices.
- Experience with pharmaceutical product development in a CRO environment.
- Excellent knowledge of FDA and/or ICH guidelines for conducting clinical research.
- Exceptional ability to conceptualize, develop and manage process solutions and work with clients in all phases or research programs
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very limited physical effort required to perform normal job duties.
- Up to 20% travel may be required including international travel
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
60549 Frankfurt am Main