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CTI Clinical Trial and Consulting Services · 1 day ago

Director Project Mgmt Lab Services

Cincinnati, OH

Full-time

Onsite

Director/Executive

6+ years exp

CTI Clinical Trial and Consulting Services is seeking a Director of Project Management for their Lab Services division. This role involves overseeing the execution of laboratory services for clinical trials, ensuring compliance with regulatory guidelines, and managing project teams to deliver quality results.

BiotechnologyConsultingPharmaceutical

Growth Opportunities

Responsibilities

Collaborate with functional areas across the lab business to develop systems, processes, templates, tools and SOPs, that will underpin the operationalization of lab services

Plan, implement, facilitate, and evaluate the full execution of laboratory services assigned clinical trials; oversee management of multiple clinical trials from the planning phase to the analysis phase for delivery to client

May function in global lead role on assigned trials and participate in day-to-day operations and/or oversight of laboratory activities and deliverables

Ensure the operational aspects of the functional areas comply with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and applicable regulatory guidelines and trial procedures

Ensure that assigned Laboratory Project Managers (LPM), Associate Laboratory Project Managers (APM) and Laboratory Project Coordinators (LPC) coordinate the organization and implementation of laboratory services for a clinical trial and manage the activities between all laboratory functional areas and the client

Serve as primary senior interface on the project with executive management at CTI and the sponsor; provide effective client management to prevent and mitigate trial issues; escalate identified trial, PM or CTI issues to management as needed; actively participate in resolution activities

Oversee preparation of all study laboratory plans and project timelines and monitor against project progress; ensure project activity compliance with plan(s); suggest and implement alternative solutions to problems with study timelines, schedules, resources, budgets, etc

Assess resource needs within team, to establish appropriate project team; monitor ongoing resource needs for all projects

Ensure that appropriate project management tools are used to track and report project progress and metrics; ensure timely entry of project information by all team members throughout the life of the project

Ensure training of assigned project teams; participate in staff training for his/her projects or other projects, dependent upon expertise

Oversee the management of budgeted hours by the PM team; evaluate and manage regional project budget against project milestones; ensure that the PM takes corrective measures where necessary to keep project in line with budget expectations

Ensure that the PM assesses scope of work against client contractual agreements and assist in changes of scope orders; provide review of changes in scope notifications and work with laboratory business operations to ensure completion of needed contract amendments

Synthesize and analyze new information against experience, project information related to trial milestones in contracts and the sponsor expectations to develop strategies to facilitate effective problem solving and advancement of the project; keep CTI executive management and the client informed; ensure that the PM initiates corrective action

Conduct or attend trial team and sponsor meetings; ensure that agendas and minutes are effectively prepared to facilitate trial communication and documentation of trial oversight, discussions, and decisions

Review weekly and/or monthly project status reports as needed prior to forwarding to client to ensure the quality of those reports, as well as all other sponsor deliverables

Report project progress, issues, and scope of work considerations to executive management

Provide input for new business development (NBD) proposals, assist in project budget preparation / review, and represent project management services during NBD client presentations; participate in new business recruitment and marketing activities; seek NBD opportunities when appropriate and communicate these opportunities to business development

Provide supervision, guidance and mentoring to PMs while encouraging independence and refinement of their skills; provide regular performance evaluation and feedback to direct reports

Review and assess internal and external quality assurance reports for assigned projects and ensure corrective action as necessary by the project management team

Provide leadership in process improvement activities and initiatives; participate in the development and enhancement of integral aspects of the LPM operations

Provide leadership and share expertise with clinical operations staff; facilitate the development of reference and resource materials for CPMs and clinical operations; participate in staff training and development activities

Coach and train others in PM practices; promote and actively participate in the professional development of all staff

Participate in business development opportunities and the enhancement of globalization processes

Qualification

Clinical Trials ManagementICH/GCP GuidelinesProject ManagementLaboratory Research ExperienceDrug Development ProcessRegulatory RequirementsCoachingMatrix ManagementSoftware ProficiencyCommunication SkillsLeadership SkillsProblem SolvingTime ManagementInterpersonal SkillsMentoringOrganizational SkillsCritical Thinking

Required

Excellent verbal and written communication skills

Ability to foster strong customer service and collegial relationships with clients, peers and other internal and external customers and promotes this in others; demonstrates effective interpersonal and positive leadership skills

Demonstrated ability to effectively manage conflict and provide leadership in facilitating problem solving by offering solutions

Ability to lead and foster collaboration and coordination amongst a diverse group (disciplines, individuals, countries/cultures) to achieve desired goals

Ability to coach, mentor, and lead staff to foster their personal and professional development

Excellent organizational, record retention and time management skills

Excellent decision-making and creative problem-solving skills

Demonstrated critical thinking skills and ability to effectively manage shifting priorities

Demonstrated strong knowledge and clear understanding of CTI SOPs

Proficient with technology and software systems

Ability to understand, interpret, and explain complex medical details

Demonstrated extensive knowledge and clear understanding of overall drug development process and medical/pharmaceutical terminology

Demonstrated expertise in ICH / Good Clinical Practice (GCP) guidelines and applicable regulatory requirements

Demonstrated extensive knowledge of global regulatory requirements related to trial management in assigned geographical regions

Able to work effectively and collaboratively in a matrix management environment

At least 6 years of laboratory research experience and/or experience in CTI project management demonstrating a clear and thorough understanding of global trial management processes and the operation of all clinical trial functional areas when combined with an advanced degree

Bachelor's Degree or equivalent in allied health fields such as nursing, pharmacy or health science

Experience in management of clinical trials

Benefits

We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward

We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department

We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade

Our culture is unparalleled – Click here to learn more about “The CTI Way”

We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program)