Clario is a 50+ year old company that delivers industry leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what’s possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence.

The Senior Lead, Clinical Project Manager is responsible for providing leadership, governance, industry expertise and best practices to our clients, client projects and the teams dedicated to serving them. The Senior Lead, Clinical Project Manager is also responsible for staff management and directing and managing services for client projects to assure high quality, on-time, and on-budget services while promoting excellent customer service.

What you’ll be doing:

Providing oversight on study management and overall project delivery by:

• Evaluating and monitoring study progress and workload of project management staff to ensure projects are on time and within budget, affecting change when necessary.
• Proactively performing risk management and mitigation with book of work under direct and indirect management
• Performing escalation management to diffuse and resolve internal and external study challenges.
• Developing and applying problem solving strategies to address customer issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to customer escalations.
• Manage internal/external negotiations and promote collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet study timelines and contractual obligations.
• Supporting Clinical Project Managers in communication with clients on study activity and risk
• Assessing workload and management of potential global projects with applicable global staff
• Interacting with various internal and external groups to facilitate successful project completion
• Performing functions of Project Manager when necessary
• Keeping senior management advised of current issues and resourcing needs.
• Working with senior management and directors when prioritization of deliverables is required for multiple projects.
• May guide study teams in being consistent across Therapeutic Area or Program as pertinent to ensure customer is consistent in study set up, optimizing efficiencies and following customer program objectives
• Coordinating routine status meetings to facilitate communications, monitor workload
• Independently lead the Start-Up, Execution, and Closeout phases of study management for to maintain technical, tactical, and operational skill sets. Study management typically are more challenging, complex, non-standard, high profile customer projects.

Identifying opportunities for greater efficiencies and quality by:

• Influence strategic decision making and implement departmental objectives according to schedule
• Assessing and upgrading the service level of therapeutic team with suggestions on new tools, processes, procedures, workflow gaps, etc.
• Owning and driving TA Initiative/Process Improvements
• Researching, evaluating and developing plan to manage assigned initiative
• Serve as Therapeutic and/or Imaging Lead for operational readiness regarding new process improvement initiatives as applicable
• Communicating plan and developing related communication (e.g. key milestones, timelines, work instructions, manual, reference material)
• Executing and reporting on plan progress
• Keeping management abreast of operational challenges and issues impacting study delivery

Performs Supervisory Functions By:

• Providing coaching and mentoring to assigned direct reports for projects and professional development
• Assist with developing training plans and on-boarding/training new members of the Project Management team.
• Ensure compliance with timely training completion/documentation.
• Mentoring and supporting career paths by developing staff aligned with Clario Project Management core competencies and critical skill sets.
• Performance management by establishing and clarifying expected behaviors, knowledge, and proficiency level.
• Collecting and monitoring defined staff metrics.
• Managing direct reports’ assignments, delegating appropriate and challenging assignments to encourage growth, development and independence.
• Providing instruction, positive models and opportunities for observation, encouraging questions to ensure understanding.
• Growing relationship by helping employees feel valued, appreciated and included in discussions.

Maintaining Quality Service and Departmental Standards by:

• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
• Establishing and enforcing departmental standards
• Reviewing and updating company SOPs related to therapeutic team
• Conducting reviews of PM compliance of performance and study management expectations and best practices ensuring high quality of deliverables in accordance with quality standards and SOPs.

Performing other duties, assignments, or special projects as time and/or circumstances necessitate.

May serve as client liaison in the following capacity (if applicable):

• Working with client and internal teams to understand the needs of the client and their projects
• Developing client specific strategies that provide for the highest level of customer satisfaction and delivery of services
• Establishing multiple tools for obtaining client feedback and gauging client satisfaction
• Addressing client requests and concerns

May serve as point of contact for focus areas across Therapeutic Area(s) and/or other Lines of Business (LOB)

May support Business Development efforts:

• Attend client meetings with business development and/or operational teams to present company services and operational data flow, as needed and participate in sales initiatives.
• Collaborating with bd director in the development and presentation of company capabilities calls/meetings
• Attending industry meeting(s) as company pm representative and projecting solid comprehension of project/protocol and company services

Contribute to team effort by:

• Exploring new opportunities to add value to organization and departmental processes
• Helping others to accomplish results
• Performing other duties as assigned and deemed necessary

What we look for:

Education:

• Bachelor’s degree in life sciences, pharmacy, nursing or equivalent required; Master’s degree preferred
• Project Management skills or experience within the industry, including expertise in primary service line and/or support of studies in multiple service lines.

Experience:

• Previous management or project experience in clinical development of investigational medications required
• 5-10 years clinical trials experience within a CRO or pharmaceutical research organization required; with an emphasis on project management.
• Medical Imaging experience a plus
• Knowledge of the drug development process.
• Working knowledge of GCH, ICH guidelines and FDA regulations

• Demonstrated ability to mentor staff.
• Excellent organizational, interpersonal, time management, and prioritization skills.
• Excellent verbal and written communication skills, including ability to communicate effectively in English.
• Working knowledge of Microsoft Office products.
• Detail and goal oriented and demonstrated responsiveness to inquiries and requests.
• Valid passport and ability to travel approximately 20%.
• Ability to maintain professional and positive attitude.

Working conditions:

Travel: 0-15%

Lifting: 0-15lbs

This job description should not be deemed all-inclusive.  Additional requirements and expectations may be assigned.  At all times, employees are expected to adhere to company policies and company SOPs.

EEO Statement

Clario is an equal opportunity employer.  Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.