ro-230

Biomarker Operations Project Manager / ro-230

Location
4056 Basel
Start
asap
End
26.09.2022
Workload
100 %
All-in / Hour
please ask us
Total Hours
1.760h

Deadline:

Deadline
05.11. 08:30am

 

ro-230

Biomarker Operations Project Manager / ro-230

Location
4056 Basel
Workload
100 %

Start

asap

End

26.09.2022

DEADLINE

Deadline
05.11. 08:30am

  • 4056 Basel
  • ro-2304056 Baselasap26.09.2022100 % 1.760hplease ask usDeadline
    05.11. 08:30am

For our customer located in Basel/Switzerland we are currently looking for a: Biomarker Operations Project Manager (m/f/d)

  • Location: CH-4056 Basel
  • Branch: pharma
  • Duration: 11 months +

Tasks & Responsibilities

As a member of global Study Communities, the Biomarker Operations Project Manager ensures the timely and efficient delivery of all biomarker operational aspects of multiple Oncology clinical studies (PhIb-IV) supported by Product Development.

In this role you are accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples in accordance with time, cost and quality commitments including ICH/GCP and applicable regulations. You collaborate closely with biomarker scientists and Biomarker Operations Program Leaders to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple Study Communities. You maintain effective working relationships with particular focus on the operational team, biomarker scientists, diagnostic partners, external CRO & Central Lab, and external biomarker vendors. In addition, you provide clinical biomarker operational expertise, innovative and flexible operational solutions within day to day activities and in support of the biomarker operational plan. Ideally, you are also able to identify areas of best practice and process improvements, as well as lead or be a representative on functional groups goals, initiatives and work-streams.

 

  • Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies within the Oncology Therapeutic Area through all phases (phase 1b-IV) supported by Pharma Development
  • Provides biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs)
  • Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples) * (collection, processing, analysis, data delivery process and final sample disposition)
  • Responsible for collaborating closely with biomarker scientists and Biomarker Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders
  • Develops and maintains effective working relationships with SMT members, with particular focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors
  • Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans
  • Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
  • Delivers the operational elements of the biomarker management plan
  • Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
  • Identifies areas of best practice and process improvements; may lead or be a representative on functional groups goals, initiatives and work-streams
  • Ensures study and biomarker operational adherence to ICH/GCP and SOPs

Must Haves

The ideal candidate is someone with a scientific education, around 3 year of experience with a minimum of 1 year in clinical operations in pharma. We are looking for a strong candidate able to came in and quickly support. This person should have good experience with vendor and project management working in a global matrix environment. Experience with biomarker in a pharma and clinical setting would be appreciated.

On the soft skills, the perfect candidate is able to be independent, good communications skills & team player. Someone able to navigate a large matrix, global environment.

 

  • Min Bachelor/Master in Life Sciences (biology and/or chemistry) (PhD & Post Docs are considered) 
  • Minimum 3 years of experience, with at least 1 year working in pharma and clinical operations 
  • Experience working in a global and matrix environment 
  • Strong experience with vendor and project management

Nice to Haves

  • Working with biomarkers & bio samples in pharma

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Preferred Interview Dates

  • asap

Tagged as: bio samples, BOPM, Lab, Oncology, therapeutic, vendors

Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

  • 4056 Basel
  • ro-2304056 Baselasap26.09.2022100 % 1.760hplease ask usDeadline
    05.11. 08:30am

For our customer located in Basel/Switzerland we are currently looking for a: Biomarker Operations Project Manager (m/f/d)

  • Location: CH-4056 Basel
  • Branch: pharma
  • Duration: 11 months +

Tasks & Responsibilities

As a member of global Study Communities, the Biomarker Operations Project Manager ensures the timely and efficient delivery of all biomarker operational aspects of multiple Oncology clinical studies (PhIb-IV) supported by Product Development.

In this role you are accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples in accordance with time, cost and quality commitments including ICH/GCP and applicable regulations. You collaborate closely with biomarker scientists and Biomarker Operations Program Leaders to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple Study Communities. You maintain effective working relationships with particular focus on the operational team, biomarker scientists, diagnostic partners, external CRO & Central Lab, and external biomarker vendors. In addition, you provide clinical biomarker operational expertise, innovative and flexible operational solutions within day to day activities and in support of the biomarker operational plan. Ideally, you are also able to identify areas of best practice and process improvements, as well as lead or be a representative on functional groups goals, initiatives and work-streams.

 

  • Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies within the Oncology Therapeutic Area through all phases (phase 1b-IV) supported by Pharma Development
  • Provides biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs)
  • Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples) * (collection, processing, analysis, data delivery process and final sample disposition)
  • Responsible for collaborating closely with biomarker scientists and Biomarker Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders
  • Develops and maintains effective working relationships with SMT members, with particular focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors
  • Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans
  • Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
  • Delivers the operational elements of the biomarker management plan
  • Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
  • Identifies areas of best practice and process improvements; may lead or be a representative on functional groups goals, initiatives and work-streams
  • Ensures study and biomarker operational adherence to ICH/GCP and SOPs

Must Haves

The ideal candidate is someone with a scientific education, around 3 year of experience with a minimum of 1 year in clinical operations in pharma. We are looking for a strong candidate able to came in and quickly support. This person should have good experience with vendor and project management working in a global matrix environment. Experience with biomarker in a pharma and clinical setting would be appreciated.

On the soft skills, the perfect candidate is able to be independent, good communications skills & team player. Someone able to navigate a large matrix, global environment.

 

  • Min Bachelor/Master in Life Sciences (biology and/or chemistry) (PhD & Post Docs are considered) 
  • Minimum 3 years of experience, with at least 1 year working in pharma and clinical operations 
  • Experience working in a global and matrix environment 
  • Strong experience with vendor and project management

Nice to Haves

  • Working with biomarkers & bio samples in pharma

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Preferred Interview Dates

  • asap

Tagged as: bio samples, BOPM, Lab, Oncology, therapeutic, vendors

Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

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