Covance Global Site Services Specialist II (Study Start-up Specialist) in Moscow, Russia

Job Description:

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

You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.

We are currently seeking a pro-active, driven Global Site Services Specialist II to join our expanding CoSource team in Moscow, Russia. The position is permanent and office-based at our Client’s site.

About the Job:

• Develop project specific plans for the GSS component of assigned studies

• 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 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 module

• 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/to Central IRB /IEC

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

• Provide milestone information for incorporation into weekly analysis sheets

• 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 to 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 client/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

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

• Directly manage day to day conduct with clients for stand alone feasibility activities and other feasibility activities as appropriate

About You:

•2-3 years of experience in clinical trials start up

•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)

Additionally, you will need to demonstrate:

• 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 / 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

THERE IS NO BETTER TIME TO JOIN US!

Requisition ID: 70003BR

Job Category: Clinical Research

Locations: Russia - Moscow

Shift: 1

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

You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.

We are currently seeking a pro-active, driven Global Site Services Specialist II to join our expanding CoSource team in Moscow, Russia. The position is permanent and office-based at our Client’s site.

About the Job:

• Develop project specific plans for the GSS component of assigned studies

• 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 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 module

• 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/to Central IRB /IEC

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

• Provide milestone information for incorporation into weekly analysis sheets

• 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 to 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 client/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

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

• Directly manage day to day conduct with clients for stand alone feasibility activities and other feasibility activities as appropriate

About You:

•2-3 years of experience in clinical trials start up

•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)

Additionally, you will need to demonstrate:

• 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 / 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

THERE IS NO BETTER TIME TO JOIN US!

Education/Qualifications: *

Experience: *

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.