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Clinical Project Manager (CPM)

Employer
Albion Rye Associates
Location
Tri State Area
Salary
$130,000 - $155,000 plus bonus and benefits
Start date
18 Jul 2022
Closing date
17 Aug 2022

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Job Details

Albion Rye Associates are searching for an experienced Clinical Project Manager (CPM) to join an exciting Biotech based in the US. The ideal candidate will have pervious experience as a CRA from a CRO, Biotech or Pharmaceutical environment, and have a minimum of 3+ years experience in Clinical Project Management.

The CPM will be responsible for the on-time and on-budget delivery of the study/studies, and will be pivotal in the execution of each stage of the trial, from initial conception, Study Start-Up and Site Initiation, full management of the process, through to close-out and successful outcomes.

 

Main Responsibilities:

  • Develop study plan outlining planning, execution, and closeout milestones.
  • Develop a study management plan in conjunction with the VP of Clinical Operations, and outlining target KPIs, risk assessment, and contingency planning.
  • Lead multidisciplinary Study Management Team.
  • End-to-end management of clinical studies to ensure appropriate resourcing and timely and high-quality delivery by all functional areas. Ability to identify and organize resources and services needed to accomplish tasks, set objectives, plan for contingencies, and managing time effect.
  • Develop and monitor study metrics to continuously assess study progress.
  • In collaboration with the study management team, and Marketing, develop a robust recruitment and retention data-driven strategic plan including risk assessment and contingency planning, at the start of the study and monitored throughout its duration and to close-down.

Project Analysis and Management

  • Identify critical project success factors for tracking, analysis and reporting including impact and probability of project risks.
  • Monitor and track study status, timelines, and budget expenditures; identifies opportunities and recommend implementation plan for efficiency measures.
  • Accountable for overall study budget, ensuring that all invoices are paid, issues are addressed, and revenues are booked in timely manner.
  • Ensures timely data entry, query resolution and prompt resolution of data issues.
  • Coordinate assignment of needed resources for study conduct and completion with functional area leaders; ensure appropriate staffing to accomplish project goals within budget.
  • Identify out-of-scope work and reports the scope change process to leadership.
  • Responsible for review of study budget, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members.
  • Manage clinical research coordinators and their activities on each study.
  • Ensure that study activities (personal and those of the Clinical Research Coordinators) are properly tracked and entered into the company’s time tracking/project management/resource planning software tool in a timely manner.

Leadership

  • Accountable for development, oversight and delivery of team training for specific projects.
  • Apply expertise in day-to-day clinical operations activities, collaborate with internal and external cross-functional team members to develop study documents and manuals, including protocols, ICFs, manuals, presentation decks, risk plans, etc.
  • Determines needed project processes and trains study teams; maintains study team knowledge and application of project processes.
  • Establish and communicate team performance expectations and guidelines.
  • Mentor and assist in coaching/training Clinical Research Associates and Coordinators.
  • Conduct performance reviews, calibration sessions and feedback discussions for clinical research coordinators. Perform competency assessments across his/her team and implements and monitors development plans with direct reports.
  • Manage performance of external service providers as required.
  • Participate in development and review of departmental Standard Operating Procedures (SOPs), guidelines, intradepartmental procedures, and other continuous process improvements programs, as assigned.

Qualifications

  • Bachelor’s degree in a Health or Scientific field required (minimum). Advanced degree or equivalent clinical research experience preferred.
  • 8+ years of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience.
  • Experience in Managing Oncology studies (Phase I-III).
  • Previous experience as a Clinical Research Associate (CRA) Desirable
  • Must currently live in the US and have right to work

Company

Albion Rye Associates are an independently owned recruitment partner, we support the Life Sciences industry in connecting experts across a variety of disciplines to support the effective launch of new medicines and treatments across the globe.

Responsible for hiring across the UK, Europe and the US:

* Medical Communications
* Healthcare Advertising & PR
* Health Economics
* Market Access, Pricing and Reimbursement

Find Us
Website
Telephone
+44 (0)20 3983 6025
Location
CoTribe Offices – Raven House
29 Linkfield Lane
Redhill
Surrey
RH1 1SS
United Kingdom
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