Covance Global Site Services Specialist I in Brussels, Belgium

Job Description:

Global Site Services (GSS) Specialist

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

We are recruiting for our Clinical Research Team in Brussels and are currently seeking to hire a Global Site Services Specialist to help support the team with investigative sites, CRAs and Ethics committees (EC) and you will be responsible for site start up and site maintenance.

This is a permanent, full time position, based in our office in Brussels.

About the Job

Within this position, your duties will include:

• Liaise with operational project team regarding project issues (i.e., participate in team meetings)

• Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan

• Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable

• +Review and approve core Country patient informed consents for compliance to country requirements and protocol as applicable

• Review and approve investigative site specific patient informed consents for required elements

• Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites

• Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor

• Liaise with Sponsor and Covance regulatory regarding document submission requirements

• Maintain and update document tracking, site address and contact information in the Site Information

• Assess impact of changes in study personnel and document amendments on regulatory

documents (including Informed Consent) and process/review/approve new documents according to GCP/ICH guidelines

• Assess impact of study amendments on Informed Consent and other study documents and revise and review/approve accordingly

• Prepare new investigator submission packages to Local and/ ot Central!RB /!EC

• Attend ongoing training in GCP, project specific requirements and as may generally be required

• Provide milestone information for incorporation into weekly analysis sheets

• Monitor performance of GSS team with regard to project timelines

• Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying)

• Manage set up and maintenance of investigative site files

• Understand and follow project specific and GSS policies and procedures

• Manage the drug supply vendor activities as applicable

• Develop, review and approve drug supply labels as applicable

• Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes

• Assume responsibility for the preparation and dissemination of documents according t the feasibility processes in place

• Create surveys to probe "thought leaders" and experienced researchers and clinicians in the field for expert feedback

• Assist with preparation of materials for formal clien1/industry presentations and for internal training assignments

• Apply basic understanding of data spreadsheets and tables

• Assist with entering data into spreadsheets when required

• Review and audit data tables and spreadsheets for feasibility assessments

• Conduct follow-up calls/telephone interviews with Investigators/Study Coordinators to solicit in-depth information related to feasibility and obtain further detailed information regarding potential proposals

• Prepare internal feasibility reports by summarizing information obtained during previous feasibility assessments, historical Covance study experience, and Investigator self-reported data

• Establish, conduct and maintain relevant QC processes in regards Feasibility Assessments

• Conduct QC of feasibility documents as required by the process

• Undertake literature and internet searches as required

• Act as point person for global feasibility studies as assigned: maintain open communication with global colleagues, provide feasibility study Investigator packet, collect data from appropriate regions and generate the formal report

• Mentor other GSS team members

• Effectively manage multiple feasibility projects of varying levels of complexity within agreed turnaround cycles

About You

To be successful in this position, you will need to be educated to a University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.

In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 4 years work experience in clinical research, including a strong working knowledge of the !CH guidelines and FDA, IRB!IEC regulations will be considered.

And also:

• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites

• Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe

• Good organizational and time management skills

• Excellent communication I writing skills

• Strong computer skills with an ability to access and leverage technology alternatives

• Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies

• Self-motivation with the ability to work under pressure to meet deadlines

• Works well independently as well as in a team environment

• Detail and process oriented

• Positive attitude and approach

• Multi-tasking capability

• Ability to work independently

We Offer

The opportunity to work within an experienced and highly skilled team.

Covance offers a comprehensive benefits package including health cover and a contributory pension.

Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.

At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.

There is no better time to join us!

Requisition ID: 69445BR

Job Category: Clinical Research

Locations: Belgium - Brussels

Shift: 1

Job Postings: Global Site Services (GSS) Specialist

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

We are recruiting for our Clinical Research Team in Brussels and are currently seeking to hire a Global Site Services Specialist to help support the team with investigative sites, CRAs and Ethics committees (EC) and you will be responsible for site start up and site maintenance.

This is a permanent, full time position, based in our office in Brussels.

About the Job

Within this position, your duties will include:

• Liaise with operational project team regarding project issues (i.e., participate in team meetings)

• Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan

• Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable

• +Review and approve core Country patient informed consents for compliance to country requirements and protocol as applicable

• Review and approve investigative site specific patient informed consents for required elements

• Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites

• Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor

• Liaise with Sponsor and Covance regulatory regarding document submission requirements

• Maintain and update document tracking, site address and contact information in the Site Information

• Assess impact of changes in study personnel and document amendments on regulatory

documents (including Informed Consent) and process/review/approve new documents according to GCP/ICH guidelines

• Assess impact of study amendments on Informed Consent and other study documents and revise and review/approve accordingly

• Prepare new investigator submission packages to Local and/ ot Central!RB /!EC

• Attend ongoing training in GCP, project specific requirements and as may generally be required

• Provide milestone information for incorporation into weekly analysis sheets

• Monitor performance of GSS team with regard to project timelines

• Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying)

• Manage set up and maintenance of investigative site files

• Understand and follow project specific and GSS policies and procedures

• Manage the drug supply vendor activities as applicable

• Develop, review and approve drug supply labels as applicable

• Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes

• Assume responsibility for the preparation and dissemination of documents according t the feasibility processes in place

• Create surveys to probe "thought leaders" and experienced researchers and clinicians in the field for expert feedback

• Assist with preparation of materials for formal clien1/industry presentations and for internal training assignments

• Apply basic understanding of data spreadsheets and tables

• Assist with entering data into spreadsheets when required

• Review and audit data tables and spreadsheets for feasibility assessments

• Conduct follow-up calls/telephone interviews with Investigators/Study Coordinators to solicit in-depth information related to feasibility and obtain further detailed information regarding potential proposals

• Prepare internal feasibility reports by summarizing information obtained during previous feasibility assessments, historical Covance study experience, and Investigator self-reported data

• Establish, conduct and maintain relevant QC processes in regards Feasibility Assessments

• Conduct QC of feasibility documents as required by the process

• Undertake literature and internet searches as required

• Act as point person for global feasibility studies as assigned: maintain open communication with global colleagues, provide feasibility study Investigator packet, collect data from appropriate regions and generate the formal report

• Mentor other GSS team members

• Effectively manage multiple feasibility projects of varying levels of complexity within agreed turnaround cycles

About You

To be successful in this position, you will need to be educated to a University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.

In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 4 years work experience in clinical research, including a strong working knowledge of the !CH guidelines and FDA, IRB!IEC regulations will be considered.

And also:

• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites

• Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe

• Good organizational and time management skills

• Excellent communication I writing skills

• Strong computer skills with an ability to access and leverage technology alternatives

• Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies

• Self-motivation with the ability to work under pressure to meet deadlines

• Works well independently as well as in a team environment

• Detail and process oriented

• Positive attitude and approach

• Multi-tasking capability

• Ability to work independently

We Offer

The opportunity to work within an experienced and highly skilled team.

Covance offers a comprehensive benefits package including health cover and a contributory pension.

Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.

At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.

There is no better time to join us!

Education/Qualifications: Required:

  • Working knowledge ofICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites

  • Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe

  • Good organizational and time management skills

  • Excellent communication I writing skills

  • Strong computer skills with an ability to access and leverage technology alternatives

  • Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies

  • Self-motivation with the ability to work under pressure to meet deadlines

  • Works well independently as well as in a team environment

  • Detail and process oriented

  • Positive attitude and approach

  • Multi-tasking capability

  • Ability to work independently

Experience: Required:

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work experience in clinical research, inclnding a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.

In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 4 years work experience in clinical research, including a strong working knowledge of the !CH guidelines and FDA, IRB!IEC regulations will be considered.

EEO Statement:

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.