Clinical Project Manager (Associate Director) - Oncology

Salary depends on experience
Posted on 08/18/17
11 - 15 years experience
Biotech/Pharma
Salary depends on experience
Posted on 08/18/17

1607609

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.

If working at the program level, the CPM is accountable for developing the operational strategy and managing the timelines, budgets, and quality across all studies in the 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.

Responsibilities:

  • Accountable for managing overall study timelines, budgets and quality targets
  • Accountable for building, forecasting and managing the Clinical TrialBudget
  • Leads the core study team; manages, facilitates and documents core study team meetings (e.g. meeting agendas & minutes, actionlogs and decision logs) and facilitates effective decision making
  • Ensures adequate study team resources andleads study teamcharteringto ensure that study team structure, including sub-teams, areeffective and efficient
  • Fosters optimal study team health including formal team effectiveness assessments and action planning
  • Manages study team communicationsto ensure cross-functional connectivity among study team members and supporting functional lines
  • Leadsand oversees the study riskplanning process (e.g. IQMP
  • Oversees operational metrics across study and manages trends and escalations
  • Accountable for delivery toBest In Class metrics
  • Acts as a single, authoritative source ofthe study information andleads study level status reporting per organizational norms and expectations
  • Ensures maintenance and accuracy of Standard Operating Procedures (SOP) log
  • Leads awareness andresolutionof Significant Quality Events (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 approvalsper organizational norms and expectations. Leads preparations and presents the study to operational governance
  • Providesclinical 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)inpart 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 levelteams as per the organizational expectations and asset teamcharter, 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 teamcharter
  • 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
  • Leadthe Operations Strategy including the Clinical Operations Plan along withthe Sourcing/Vendor Strategy
  • Manage anddeliverto timelines, budget and quality for all studies in a program
  • Interface with the Global Clinical Lead (GCL) and program level roles including at the CRO
  • Participate in programlevel 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 ofthedata and document delivery plans atkey milestones such asProof of Concept (POC), DP3 decisions, submissions, rapid response.Manage other submissions activities as necessary
  • Support planning and technical review of licensingopportunities and/or due diligence activities.Oversee strategic drug development partnerships and/or clinical research collaborations alongwith business development opportunities for the specific category.
  • Monitor progress againstplan; develop and implement formal operational risk management plans across the asset/program
  • Communicate opportunities andrisks to the category leadership. Ensures cross functional buy-in to risk mitigationplans and asset team’s proposals for governance endorsement appropriately capture operational inputs and risks
  • Define and execute operational transition from early tolate 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.

Skills:

  • 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 allfunctions

If working at the program level in addition to the study level, additional capabilities & skills requiredinclude:

  • Broaddrug developmentexperience
    • Understands interplay/intricacies of drug development program
    • Understands how studies fit togetherand planning involved (sees the big picture)
  • Broadproject management experience
  • Strategic thinking and targeted problem solving skills
  • Maintains scientific knowledge and expertise of indication/asset to possess credibility to discuss withhigherlevel management
  • Strong interpersonal skills

Trainingand Education:

  • Extensive clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associatedwith projectandstudy management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations
  • BSminimum of 13 yearsrelevant experience
  • MS/PhDminimum of 10 yearsrelevant experience

Prior ExperiencePreferred:

  • Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise,leaddata management expertise, clinical leadership expertise)
  • Demonstrated project management / leadership experience
  • Experience in understanding ofkey drivers impacting budgets
  • Experience in building a Clinical TrialBudget and managing project tobudget

Additional Details:

  • Eligible for Employee Referral Bonus
  • Grade 12
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