Applies and integrates of key Clinical Project Management processes and tools across clinical teams and/or subsets of clinical teams to deliver clinical milestones on time, on budget, and within scope. Monitors performance versus plan on projects. Responsible for working with others on the team to handle third party relationships (including partnerships) related to clinical development. Handle communications and ensure documentation of key clinical information and decisions. Ensure project management and clinical systems are accurate and up to date (MS Project, SAP, IMPACT etc. ).
Actively identify and communicate to the team risks that may affect the critical path of the clinical plan and schedule. Monitor the implementation of contingency plans and communicate outcomes. Ensure benchmarking and shared learning is collected and utilized for future projects. Accountable for reporting and monitoring progress of metrics to study team and management on regular basis. Document study team decisions and bring together lessons learned. Maintain clinical timelines in appropriate project management tool.
Communicate and handle critical path the team's progress relevant to major clinical milestones. Maintain clinical schedule updates on a regular basis. Client is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Being on a temporary contractor assignment at Client means working in an innovative culture where you have the opportunity to support the work of thousands of others around the globe dedicated to improving the lives of others. Client discovers and brings life-changing medicines to those who need them, improves the understanding and management of disease, and gives back to communities through philanthropy and volunteerism. Eli Client passionately promotes food security and fosters the human-animal bond to enrich the lives of its customers and the customers they serve as well. Our values: integrity, excellence, respect for people. Greater than 90% of workers rate their Client assignment as above average or excellent.
CORE JOB TASKS
This job description is intended to provide a general overview of the job requirements at the time
it was prepared. The job requirements of any position may change over time and may include
additional responsibilities not specifically described in the job description. Consult with your
supervision regarding your actual job responsibilities and any related duties that may be
required for the position.
- Clinical Planning and Execution: Role-based Training Plan (Clinical Operations I)
- Accountable for oversight of clinical operations and delivery of clinical project milestones on time and on budget
o Create and manage implementation timeline and clinical trial activities via the
Chorus custom database and Project Management tools
o Accurately forecast and track direct expenses for clinical budgets
Document key team information and clinical decisions in Chorus custom
tracking and communication database
o Manage clinical operational risks and their impact to the timelines and
budgets of clinical studies, including critical path activities
- Select and manage external network of vendors to ensure on time and on budget clinical project deliverables
o Establish and manage Clinical vendor expectations, performance, and delivery
- Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward
- Partner with regulatory and medical to ensure safety management and monitoring processes are implemented
- Provide input into molecule development, clinical regulatory and safety strategy
- Manage global cross-functional communication and escalations to ensure alignment on delivery and execution
- Utilize clinical operations process knowledge to drive decision making.
- Participate in review of clinical database specifications and utilization
- Manage the writing and approval of informed consent documents
- Initiate clinical change control process for studies, as appropriate
- Maintain a state of inspection readiness for clinical development inclusive of TMF.
- Model essentialism and judgement-based decision making to navigate compliance and quality requirements.
Leadership: Role-based Training Plan (Chorus Line Management)
- Ensure direct report competencies evolve and address implications to overall resource management and strategies.
- Consistent demonstration of the leadership behaviors
- Excellent oral and written communication skills
- Proactive communication with asset team members
- Strong problem-solving skills
- Excellent self-management and organizational skills
- Practical experience leading a team of people to deliver on an objective
- Able to exercise sound judgment and take and defend tough positions
- Ability to use sound judgment when interacting with various sponsors (internal and external) while maintaining the Chorus brand image
- People Management: Role-based Training Plan (Chorus Clinical Operations I)
- Recruit, develop and retain a diverse and highly capable workforce
- Build an organizational culture that fosters diversity, equity, and inclusion
- Ensure robust training plan and timely completion of required training for direct Reports.
MINIMUM JOB REQUIREMENTS (e.g., educational background, work history, etc.) :
- Bachelor’s degree, preferably in a scientific or health-related field
- Minimum of 5 years’ experience in the pharmaceutical industry and/or clinical development
- Early phase clinical trials operations experience preferred, but not required
- Must understand clinical development processes and the interdependencies of various tasks that require coordination among asset team, functional/regional team members and third parties
- Demonstrated core project management skills through management of complex/cross-functional projects, and/or clinical trials with a strong knowledge of regulations and guidelines
- Must be capable of managing cross-functional staff in Cork, Ireland
- Proven ability to coach and develop others
- Ability to embrace the diversity of thought to model innovative behaviors (e.g.,
reaching across boundaries, inspire and empower others and lead decisively in the midst of ambiguity)
- Strong communication skills; able to communicate clearly and succinctly with team members and leadership
- Ensures effective cross-functional communication with internal and external experts
- Project Management certification (e.g., PMP)
- Previous supervisory experience
- Prior experience in working with a non-Client business partner (e.g., CRO, Alliance, Joint Venture)
- Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
- Able to influence others without direct authority
- Strong problem-solving skills: able to anticipate and recognize systemic problems, diagnose root causes, and take corrective actions to prevent