Clinical Project Manager I&I (Director) - Groton, CT | Biospace
Get Our FREE Industry eNewsletter

Clinical Project Manager I&I (Director)

Pfizer Inc.

Apply
Location:
Groton, CT
Posted Date:
8/18/2017
Position Type:
Full time
Job Code:
1609476
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

  • This is a remote based or onsite role.

The Clinical Project Manager (CPM) will lead and manage the core cross functional study team and is the single point of accountability for the operational delivery of one or more clinical studies from concept through reporting, including inspection readiness, submission and regulatory defense. The CPM is an expert on the operational delivery of clinical trials and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies). The CPM will be responsible for developing timelines and budgets for their clinical studies and leading the execution of these studies according to time, cost and quality targets. The CPM is responsible for proactive operational risk management for their clinical study(ies). This role will be accountable for planning and delivery to the Best-in-Class targets as well as optimal resourcing of the study team(s) and ensuring optimal study team(s) health.

CPM at Director level will be accountable for developing the operational strategy and managing the timelines, budgets and quality of large or complex studies and /or all of the studies within a less complex program. This includes understanding and planning how different studies fit together (e.g. how the readout from a study informs the next steps and overall program strategy). It may also include planning and oversight of strategic drug development partnerships and/or clinical research collaborations along with business development opportunities for the specific category.

May be required to provide supervision to other CPMs within a program.RESPONSIBILITIES

  • Accountable for managing overall study timelines, budgets and quality targets
  • Accountable for building, forecasting and managing the Clinical Trial Budget
  • Leads the core study team; manages, facilitates and documents core study team meetings (e.g. meeting agendas & minutes, action logs and decision logs) and facilitates effective decision making
  • Ensures adequate study team resources and leads study team chartering to ensure that study team structure, including sub-teams, are effective and efficient
  • Fosters optimal study team health including formal team effectiveness assessments and action planning
  • Manages study team communications to ensure cross-functional connectivity among study team members and supporting functional lines
  • Leads and oversees the study risk planning process (e.g. IQMP)
  • Oversees operational metrics across study and manages trends and escalations
  • Accountable for delivery to Best In Class metrics
  • Acts as a single, authoritative source of the study information and leads study level status reporting per organizational norms and expectations
  • Ensures maintenance and accuracy of SOP log
  • Leads awareness and resolution of SQEs and escalations
  • Leads the study work order and change order processes
  • Ensures comprehensive operational input to protocol design
  • Monitors and remediates quality metrics and completes remediation tracker
  • Responsible for inspection readiness
  • Ensures Quality Gate timing planning, and team readiness
  • Responsible for obtaining requisite operational governance approvals per organizational norms and expectations. Leads preparations and presents the study to operational governance
  • Provides clinical timelines, cost, and operational risk sections of the governance presentations, memos, and other materials used for decision making. Participate and may present assigned study(ies) in part or in full to technical and executive governance.

If taking on program level work in addition to study level work, additional responsibilities include:

  • Represent clinical operations on the asset level teams as per the organizational expectations and asset team charter, serve as a single point of accountability for operational delivery of clinical programs
  • Lead clinical operations' sub-team(s) where appropriate, e.g. for large programs with multiple studies, in accordance with the organizational expectations and asset team charter
  • Define optimal operational strategy and define timeline, resourcing and budget needs for execution of the clinical plan for the asset/program including early development candidates, concept plans (such as in support of the lifecycle and operating plan process) and for the licensing and partnership opportunities
  • Establish and ensure adherence to operational standards and best practices for the asset or program
  • Lead the Operations Strategy including the Clinical Operations Plan along with the Sourcing/Vendor Strategy
  • Manage and deliver to timelines, budget and quality for all studies in a program
  • Interface with the GCL and program level roles including at the CRO
  • Participate in program level feasibility & country strategy
  • Attend and represent Clinical Operations at governance meetings (including co-development studies)
  • Manage & support escalations
  • Inspection management & readiness
  • Develop and lead execution of the data and document delivery plans at key milestones such as POC, DP3 decisions, submissions, rapid response. Manage other submissions activities as necessary
  • Support planning and technical review of licensing opportunities and/or due diligence activities. Oversee strategic drug development partnerships and/or clinical research collaborations along with business development opportunities for the specific category.
  • Monitor progress against plan; develop and implement formal operational risk management plans across the asset/program
  • Communicate opportunities and risks to the category leadership. Ensures cross functional buy-in to risk mitigation plans and asset team's proposals for governance endorsement appropriately capture operational inputs and risks
  • Define and execute operational transition from early to late phase development and for the in-licensing and acquisition opportunities
  • Represent CD&O on the operationally-focused co-development teams with another development partner(s), where applicable

    Requirements

    Training and Education:

    • Extensive clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associated with project and study management, knowledge of GCPs, monitoring, clinical and regulatory operations
    • BS - minimum of 13 years relevant experience
    • MS/PhD - minimum of 8 years relevant experience

      Prior Experience:
    • Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise, lead data management expertise, clinical leadership expertise)
    • Demonstrated project management / leadership experience
    • Experience in understanding of key drivers impacting budgets
    • Experience in building a CTB and managing project to budgetSkills:
    • Ability to lead cross-functional teams, identify, resolve & escalate issues
    • Ability to represent & communicate clearly at Governances
    • Ability to understand and assimilate high-level data from all functions

      If working at the program level in addition to the study level, additional capabilities & skills required include:
    • Broad drug development experience
      • Understands interplay/intricacies of drug development program
      • Understands how studies fit together and planning involved (sees the big picture)
    • Broad project management experience
    • Strategic thinking and targeted problem solving skills
    • Maintains scientific knowledge and expertise of indication/asset to possess credibility to discuss with higher level management
    • Strong interpersonal skills

    EEO Statement

    EEO & Employment Eligibility

    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Sunshine Act

    Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

    Additional Offer Details:

    • Grade: 15
    • Additional Location Information: Virtual
    • Eligible for Employee Referral Bonus