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Program Manager, Clinical Adjudication

Bioclinica


Program Manager, Clinical Adjudication

Primary Responsibilities
Responsible for the management, service harmonization, and ultimate delivery of a seamless customer experience for Bioclinica’s program level adjudication accounts with senior level accountability for overall client satisfaction and program profitability. Serving as an effective bridge between the Sales and Operations teams, create a direct link and stronger collaboration between Customers and Operations. Work with the study team to understand their business needs and coordinate with the Operations team to improve business performance, enhancing both client satisfaction and operational efficiencies. Work directly with both Account Managers and Project Managers to coordinate internal department deliverables against client strategic initiatives.

Ensures program success by:

  • Maintaining thorough knowledge and understanding of adjudication capabilities, processes and technology
  • Developing, communicating and executing a “program plan”; identifying critical success factors for tracking, analysis and reporting including Governance forums / standards
  • Analyzing performance and identify enterprise needs and develop creative solutions to address those needs
  • Developing, communicating and monitoring corrective action plans as needed. This includes sharing and reinforcement of best practices throughout program management group
  • Surveying key stakeholders; includes conducting client satisfaction and operational surveys, analyzing responses and making recommendations
  • Drives operational efficiencies via standardization to drive quality, productivity, and customer satisfaction
  • Guides the customer and leads internal teams on customer specific paradigms, document templates, data management standards, communication plans, status reporting, and any area where operational efficiencies are required
  • Ensures all Project Managers working for a client are trained on the customer specific guidelines
  • Provides mentorship to Clinical Project Managers and Assistant Clinical Project Managers.
  • Provides input into the onboarding project planning and staffing preferences for accounts.
  • Recommends an escalation path for accounts if a serious issue causes escalation above the Project Manager.
  • Identifying changes in scope and budget overages necessitating change orders
  • Available to attend and present at bid defenses as internal SME
  • Keeping all teams up to date on recent events, client news, strategic client initiatives and any material changes in the client goals and objectives
  • Maintaining thorough knowledge and understanding of client contracts, deliverables, business practices and key performance indicators. This includes maintaining thorough knowledge of all client agreements (e.g., Service Level Agreement, Governance Agreements, Rate Cards)

Ensures optimal program productivity and identifies opportunities for enhanced efficiencies and quality by:

  • Evaluating and monitoring progress and workload of program teams for key accounts to ensure studies are successfully executed on time and within budget; affecting change when necessary
  • Working with senior management and directors when prioritization of deliverables is required
  • Assessing and upgrading the service level of the program management team with suggestions on new tools, processes, procedures
  • Preparing meaningful metrics and reports for senior leadership while attending relevant BD discussions
  • Partnering with management to develop project team staff and retain highly qualified staff

Provides operational support to internal teams as the account expert by:

  • Providing timely updates to internal teams; reporting on critical project status, risks, escalations and achievements
  • Addressing problems through risk management and contingency planning, presenting solutions and/or options to Senior Management
  • Sharing learning and best practices as appropriate
  • Providing applicable training to Project Management staff

Maintains 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 department

Secondary Responsibilities
Contributes to team effort by:

  • Working with internal staff to resolve issues
  • Exploring new opportunities to add value to organization and departmental processes
  • Helping others to achieve results
  • Performing other duties as assigned

Qualifications
Education:

  • Bachelor’s degree in a health-related field or management; advanced degree preferred

Experience:

  • 5+ years clinical research experience with a minimum of 3 years in a client relationship, management or program management role (Comparable combination of education and experience may be considered)
  • Experience in multinational business operations preferred
  • Progressive management responsibility with strong negotiation and influencing skills
  • Working knowledge of GCP, ICH guidelines and FDA regulations
  • Thorough knowledge of medical and pharmaceutical industry, terminology and practices

Additional Skills:

  • Works independently with little to no supervision or oversight, required
  • Ability to manage projects with increased complexity
  • Ability to delegate power and authority to a person acting as a representative
  • Strong client management to minimize non-standard sponsor requests and escalations
  • Strong interpersonal and communication skills, both verbal and written
  • Strong organizational and leadership skills
  • Goal oriented
  • Ability to maintain professional and positive attitude
  • Strong presentation and negotiating skills

Working conditions
Travel: 0-20%

Lifting: 0-15lbs

Other: Computer work for long periods of time



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Bioclinica - hurtigt overblik


Bioclinica
Bioclinica
Bioclinica utilizes science and technology to bring clarity to clinical trials: helping companies to develop new life-improving therapies more efficiently and safely.

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Axeltorv 2
1609 København V
Logo: Bioclinica
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