My short profile

SUMMARY OF EXPERIENCE

  • 28 years of experience in clinical research
  • 15 years in executive leadership positions in Clinical Operations
  • 13 years in project management and account management (BigPharma and BioTech)
  • Strong focus on client management, staff, and change management
  • Experience in building structures and process for clinical organization of different sizes (350 to 600)
  • Experience in building structure for clients and client interaction
  • Experience in quality management and training
  • Strong competencies in pricing, cost management, vendor selection and management
  • PM / TA experience in II-V oncology, CV, autoimmune disease, vaccines
  • Very competent in intercultural and virtual team management

Building Processes and Structures

Company
Karwoth GmbH

CRO business

Responsibility
Build simple QM structure and processes to support business in a small boutique CRO and be set up for vendor selection audits.

Period
Q3 2020

Project

  • Defining and creating SOPs to support Process and quality management
  • Establish a process for hiring
  • Establish Training CV and tracking
  • Establish standards for communication and training
  • Creating Job descriptions and contract standards
  • Management and strategy support for Business Owner

Outcome

  • New SOPs created; review process established
  • Training CV template established and implemented
  • Add required training rolled out, training routine set up
  • Support for preparation, conduct, and reporting of 2 inspections

Success factor “staff turnover”: vendor capability inspection by a new client, investigating process in line with GCP and standards passed. Inspections successfully prepared, managed, and closed.

Company
Parexel GmbH

CRO business

Responsibility
Build management team, structure and processes to run a clinical operations leader department in EU,

Period
Start Q2 2009, time to deliver 6 weeks for new department structure, 3 months for SOPs

Project

  • The building of a new department for Clinical Operations Leaders (COL) to guarantee standardization in competencies, training, and development for staff across Europe.
  • Build within 6 weeks a solid structure to allow staff to move out of the current clinical department under the new COL department without disruption of ongoing business the staff was assigned to.
  • The project included the creation of a new set of competencies, new job descriptions for all potential levels, including managers, and deciding on SOP building or integration into existing SOPs and completion of this latter task.

Outcome

  • 350 staff successfully transferred from clinical operations into the new department respecting local labor laws within 6 weeks
  • 27 competent managers selected and hired from the EU wide clinical operations Management group within 6 weeks.
  • SOP integration into Clinical Operations SOPs within 3 months

The whole process did not result in any disruption of projects, no exchange of staff was needed. All staff agreed to move to the new department.

Success factor “staff turnover”: zero turnover after transition and onwards all-time low turnover for staff (below 5%) and LMs (below 1%). Department structure still in place after 10 years.

Company
Parexel, GmbH 

CRO Business

Responsibility
Build a capacity planning structure for the Clinical Operations Leaders Department to manage and forecast resources efficiently

Integration into existing sales and proposal processes and requirements.

Period
Time to deliver 6 months

Project

Planning capacity 6-12 months in advance to ensure staff availability on time and in line with project forecast

Expertise in profile tracking of staff, respecting data protection laws to match staff with project requirements

The project included building a sustainable technical platform as well as a team structure to manage the review and assignment going forward.

Outcome

  • Lotus notes DB build and data for all 350 staff and project assignments entered
  • Forecast capacity planning build in for 6, 9, and 12 months
  • Interfaces with relevant sales platform (clientlink) integrated for an early alert on new projects
  • Interface with project view build-in to feed project real start and end dates
  • Experience DB rebuild and data of 350 staff entered
  • Team recruited and trained to maintain and manage data, consisting of 1 Lead Resource Manager and 3 Junior Resource Manager
  • Process build for routine weekly resource review
  • All department managers trained on the new resourcing process to provide updates to the resource management team weekly

Success factor: 

Capacity planning for the COL group was in line with project needs and 12 monthly accurate forecasts available.

Assignment matched project needs, positive feedback from sales

The COL resourcing office served as a role model for the company to build a companywide Project Resourcing Office 5 years later.

Company
Parexel, GmbH 

CRO Business

Responsibility
Build a knowledgeable team of managers in Clinical Operations, capable to understand the pricing tools and provide strategic and pricing relevant input into client proposals representing WW Clinical Operations.

Ensure alignment with existing sales and proposal development processes and requirements.

Period
Time to deliver 3 months

Project

  • Alignment of expectations with the proposal development group and workload estimation based on monthly scope of proposals.
  • Definition of the resourcing requirement (non-dedicated LM) 
  • Selection of interested and skilled ~40 LM and SLM across clinical Operations
  • Training definition, building & roll out
  • Establish ongoing mentoring

Outcome:

  • Clinical Reviewer group was set up globally within the timeframe of 3 months
  • Proposal reviewer assignments build into sales project for an automated request of clinical proposal reviewers WW
  • Defined, described, and agreed with sales clear scope for clinical input
  • Training material created and delivered training on contracting, pricing tool algorithms, and cost drivers, and proposal text. 
    • Initial training delivered to all reviewers WW
    • 6 weekly forums were established to provide ongoing training and lessons learned.
  • Established ongoing mentoring contacts at a senior level in ClinOps/Sales WW for reviewers to provide quick support. 

Success Factors:

Selecting clinical operations LMs for proposal review enhanced the quality and strategic approach of proposals and as “site effect” enhance the financial knowledge in the LMs group

Company
Parexel, GmbH 

CRO Business

Responsibility
Create a robust, not tasked based pricing model to support pricing and resource planning for clinical operations leaders.

Period
Time to deliver 2 months

Project

  • Develop a pricing model that enables pricing for COL resources.
  • Scalable from single country / single site to WW studies / > 500 sites
  • Include adaption for pricing during study start-up and conduct of a clinical trial

Outcome:

  • An adjustable model developed, scalable by countries and sites
  • Robust to provide pricing and resource forecast for all type of studies in Phase2-4

Success Factors:

The model has proven successful in terms of pricing and resourcing for about 10 years, allowing alignment of resource needs to project requirements and execution in the budget.

Staff management

Company
Parexel GmbH 

CRO Business

Responsibility
Develop solid competencies for the Clinical Leader role with HR, including a process for regular assessments against those to identify training needs and drive change and development of staff.

Develop competency-based tools for interviewing and career progression, with a view on staff retention.

Period
Competency setting – 3 months

Regular competency assessment – ongoing

Project

  • Use industry-standard for competencies for project leader roles
  • Easy to implement and maintain with limited time effort after implementation
  • Linked to training and development 

Outcome:

  • Initial competency model build
  • Integrated into the yearly performance process
  • Trained LMs and rolled out to LMs and staff
  • 2 yearly review established with reporting out and linked to training plans
  • Competency-based interview tools developed for all Clinical Lead levels
  • Standards defined for career progression within the company and external staff

Success Factor

  • Competency settings and assessment tool allowed targeted training to close gaps and allow career progression for staff
  • Interview tools resulted in targeted hiring of the right fitting candidates; reflected also in low turn over rates (EU < 5%, US < 10%, AP < 10%)

Client management

Company
Parexel, GmbH 

CRO Business

Responsibility

Provide functional oversight for all clinical trial aspects for portfolio transition between 2 clients and transfer to the vendor for selected clinical trials.

Period
3 months

Project

  • Transfer of projects from 1 client to other client and transfer to vendor (PXL); covering all aspects as submission and notification requirements and status, CTMS transfer, eTMF transfer, staff training, and system access, site transfer
  • Resourcing for all trials transferred to the vendor in time for handoff by pharma company

Outcome:

  • Successfully managed the transition between 2 pharma companies and transfer of selected trials to vendor CRO including 
  • Full CTMS data transfer
  • eTMF transferred and issue status agreed
  • Vendor staff selected, assigned, and system access organized for all required client system
  • Training access and completion for all staff in time
  • Authorities and ECs informed
  • Site for clinical trials informed, Vendor CRO staff introduced and handover arranged.

Success Factors:

  • All transferred studies could continue during the transition period without any interruption.

Please send me your documents as PDF files.

Yasmin Limbach
Lauterstr. 3
12159 Berlin

+49 174 917 2941
+49 30 83 22 54 43