Clinical Project Manager / Senior (CPM)
- Employer
- Albion Rye Associates
- Location
- Maryland, United States (remote working considered)
- Salary
- Generous salary range, experience dependent.
- Start date
- 18 Jul 2022
- Closing date
- 17 Aug 2022
View more
- Discipline
- Clinical Research, Clinical Project Manager
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
Clinical Project Manager II / Senior - US (remote positions available)
Albion Rye Associates are searching for an experienced Clinical Project Manager (CPM) to join a small, reputable client based in the US. The ideal candidate will have pervious experience as a CRA from a CRO environment, and have 2+ years experience as a CPM from either a CRO or Biotech.
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, 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 Director of Clinical Operations, and sponsor representative(s) 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.
- Mentor and assist in coaching/training Clinical Research Associates and Coordinators
- Assist in screening, selection, and management vendors in accordance with contractual timelines, sponsor specifications, quality, budget, and GCP.
- 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 required. Advanced degree or equivalent clinical research experience preferred.
- 8+ years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience.
- Experience managing various studies with a CRO
- Experience in Oncology, CNS, Endocrinology or Rare Diseases preferable.
- Previous experience as a Clinical Research Associate (CRA) Desirable
- Must currently live in the US and have right to work
Company
At Albion Rye Associates, we create a bespoke recruitment process that is thorough, professional, personable – and most importantly, tailored to exactly to what you need.
We have a clear focus on collaboration and communication. We are solutions-led and know from vast experience that for successful outcomes to be reached, we don’t just work for our clients and candidates – we work with them.
Our valued clients and candidates have the highest of standards and expectations. We are exactly the same. If we weren’t, they wouldn’t want to work alongside us. We ensure that every client and candidate receives the made-to-measure, personalised recruitment service that they want, need, and deserve through building long-term working relationships.
- Website
- https://www.albionryeassociates.com/
- Location
-
CoTribe Offices – Raven House
29 Linkfield Lane
Redhill
Surrey
RH1 1SS
United Kingdom
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