Sr. Project Manager, Clinical Trials- Boston ( Hybrid)

Our CRO client with a global reach is looking to add a Sr. Project Manager to their Boston team to provide project leadership and organization to supported select cardiovascular clinical trials within the organization. 

The candidate will assure the growth of revenue and profitability by providing quality, client-oriented, clinical operations services while maintaining departmental standards of excellence and compliance with project-specific financial targets. 

The candidate will manage the Project Team associated with specific clinical trials, with responsibility for performance and proficiency at the project level. Provides support in client negotiations, internal process implementation, and trend analyses. Additionally, mentoring and execution of department goals and process improvement are within this remit.

Responsibilities:

  • Responsible for supporting the strategic direction of the PMO under appropriate management
  • Responsible for project management performance for assigned projects
  • Assure project compliance with SOPs, CAPA completion and defined departmental metrics
  • Assures compliance with Good Clinical Practices (GCP) within all project-related functional areas
  • 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
  • Responsible for building and maintaining positive client relationships
  • Ability to negotiate with clients to assure company operational processes are maintained, projects are done within scope
  • Assigned as Project Lead for high visibility clients and projects; 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 CTMS 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 CEO or designee as escalation is necessary. Success will be defined by strong management of project operations for those projects within the reporting structure
  • 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
  • Success will be defined by tight management of project finances for those projects (in conjunction with the CFO) within the reporting structure. Authorized to work with CFO to hold client deliverables when deemed appropriate for financial or quality reasons
  • Oversees or designates external organizations’ project interactions. Supports the company in the management of any operational vendor relationships as necessary
  • Responsible to maintain documentation for SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at every instance of out of office

Experience, Skills and Abilities:

  • Experience in managing global operational teams
  • Experience in the cardiovascular therapeutic area or demonstrated expertise preferred
  • Strong leadership skills including project-related financial management, problem solving, employee development and negotiation
  • Knowledge of clinical research process from Phase I through regulatory submission
  • 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
  • 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 and clinical 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 and/or device product development
  • Excellent knowledge of regulatory and 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

MINIMUM RECRUITMENT STANDARDS:

Previous Management Requirements:

  • US Bachelor level or equivalent in a health-related field or advanced business degree (5 year or equivalent) with at least five (5) years of demonstrated clinical trials management experience OR appropriate clinical experience with ten (8) years of clinical trials management experience
  • And, within the total years of experience, at least four(4) years of management experience in a contract clinical research position is required.
  • At least 2 years of experience at the Manager Level or above
  • Experience in clinical monitoring and/or data management is preferred; experience in electronic data management is preferred.
  • Excellent demonstrated knowledge of issues affecting data analysis for clinical trials required.
  • Excellent written and verbal communication and presentation skills required.

If interested, please email Earl Callender at ecallender@daleyaa.com.
 

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