Senior Strategic Project Planning Specialist

il y a 1 semaine

RueilMalmaison, Île-de-France Labcorp Temps plein

Senior Strategic Project Planning Specialist - Phase I, Remote:

Grade - P2-1
-
Do you have Phase I-Ib clinical trial experience?
-
Experienced preparing and interpreting Phase I budget proposals?
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Have knowledge of the operational nuances within Phase I study design and related budget impacts?
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Interested in joining a new team, with some client-facing exposure, where you will work closely with commercial and operational teams?
Fortrea is recruiting for a Senior Strategic Project Planning Specialist. You will support the CPS (Phase I) clinical development strategy and planning team.

You will also support our external site partnership network by understanding site capabilities and experience, study feasibilities and key metrics critical to the success of the business, and optimisation of CPS.


We are looking for someone who will work closely with commercial and operational teams, providing external site analytics, feasibility information, site capability, country-specific and multi-centre strategy considerations.

You will maintain the Strategy & Planning Study Resourcing database for our clients in support of CPS clinical trials.


You will actively support the growth of the business through feasibility, data collection and analysis, study planning support, and provides new insight to grow commercial activities through data driven solutions.


As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.


Opportunity is available for those located in the UK, Romania, France or South Africa

Essential Duties:

Strategic Planning Support (i.e., site network capabilities, data analysis and interpretation for
feasibility, strategy and planning, etc.) - 70%

  • Assist in study feasibility, assessment and the development of strategic study plans by providing the relevant information for business opportunities, including industry intelligence, literature resources, client solutions and objectives.
  • Leverage CPS software tools and databases to generate data in support of:
  • Global feasibility
  • Enrollment estimates
  • Site Performance Analytics
  • Study timeline projections for resourcing
  • Identifies list of potential external sites to support strategy based on feasibility assessment, capabilities, SPA data, experience and risk.
  • Conducts site outreach, interest and feasibility, prepares redacted synopses, SOEs, and protocols for external site outreach.
  • Accountable for the CPS Strategy & Planning Study Resourcing database upkeep, analysis and presentation of key metrics for implementation of external site strategies for CPS clinical trials.
  • Analyze data and report metrics on external sites for pre
- and post-award study deliverables
  • RFIs/RFPs, BDMs, client calls, capabilities presentations, site governance and escalation or investigations, etc.
  • Produce reports and outputs with mínimal supervision from more senior department staff.
  • Accountable for site deliverables in support of Request for Proposal (RFP) and Request for Information (RFI) including timelines, budgets, proposals, information for BDMs, issue escalation, etc.
  • Reviews strategies for completeness and quality in white papers, executive summaries, key parts of proposal documents, feasibility assessments, competitive pipeline analyses and other strategy documents.
  • Deliver accurate, high quality deliverables to timelines and expectations.
  • Active participation on crossfunctional teams that plan, analyze, and implement shortterm and longterm solutions to drive new business initiatives.
  • Supports S&P team in refining external site strategies upon scope change, rescue, or sponsorrequested changes.
  • Identifies and communicates potential projectspecific or external site risks, quality concerns, issue or conflict escalation and works together with Strategy & Planning Leadership on mitigation and resolution.
  • Provide updates on monthly applicable site metrics for department, including metrics for external site quality, audit history, issue escalation and resolution in support of site success initiative external site feedback pre, during, and poststudy follow up.

Department Support - 30%

  • Maintain external network structure (core/primary, secondary, tertiary) for rapid study startup, and works with external network to progress towards primary partnerships.
  • Assesses external site and study risk, proactively engages leadership, site, and project management to mitigate risk.
  • Participate in the preparation of appropriate user manual / work instructions.
  • Identify

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