Clinical Research Study Manager
- Recruiter
- BCT Resourcing
- Location
- Uxbridge, London - East
- Salary
- £311 per day
- Posted
- 16 Sep 2016
- Closes
- 14 Oct 2016
- Ref
- 1315624
- Contract Type
- Contract
- Hours
- Full Time
Title: UK CW Clinical Research Study Manager
Salary: £311 per day
Location: Uxbridge (office- based role)
Job Type: Contract (6 Month, 7.5 hours per day )
Company Introduction:
Client is a Multinational Biopharmaceutical Company headquartered in California. Client is the world's largest independent biotechnology firm. Client focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. Client has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Main duties for this role:
Track receipt of ISS concepts/proposals from Investigator Sponsor
Facilitate communication with Sponsor via collaboration with TA/Medical staff (eg: acknowledgement of receipt of proposal, provision of scientific comments on protocol)
Complete sponsor qualification process (in collaboration with TA/Medical staff as needed)
Facilitate categorization, review and approval of ISS proposals with medical personnel (including documentation)
Initiate and ensure execution of Confidential Disclosure Agreement where necessary
Facilitate team review process/sign off for proposals, protocols and amendments and submit for re
view by Exec Medical Director/GDL or review committee eg: GPRC, IPRC
Support meetings internally (e.g. GDT, product-specific ISS Review meetings, IMT, NAMT, Finance) and with Sponsor as appropriate (creating agendas, minutes, etc)
Provide protocol submission package including product specific safety information, details of firm’s ISS process and requirements to sponsor for protocol review and start-up activities
Partner with Global /Regional Operations representative regarding drug forecasting including ancillary supplies, clinical trial labelling activities, expiry dates/memos as appropriate
Partner with GCP&P on budget negotiations and ensure conduct of Fair Market Value assessment
Collaborate with GSM to notify Sponsor of any actions or information required from Due Diligence process
Initiate and support the contract execution process in collaboration with legal
Support the collection of ISS Approval Package (ISSAP) documents and forward for signature approval
Enter data (e.g.. milestone tracking, enrolment status) and maintain source systems
Track essential documentation and archive in TMF
Procure updates from the Sponsor regarding enrolment, milestone payments, etc, per contract and initiate and track invoices and payments per contract
Ensure the provision of safety updates to Sponsor in collaboration with Safety
Liaise with external CRO vendors appointed by the sponsor as necessary
Assist Global Operations with product reconciliation and destruction as appropriate
Co-ordinate review of publications as necessary
Support training and co-ordination of local ISS Associates and GCSM staff (regional role only)
Manage direct reports and/or act as mentor to develop Associates/Sr. Associates (where relevant, and excluding LOC staff)
Review ISS metrics, assist with measurement of compliance to process requirements
Communicate ISS status to management as requested
Identify and facilitate resolution of ISS cross-functional issues; lead cross-functional task forces or working groups under supervision of Senior Manager
Requirements:
Experienced CRSM required to project manage Investigator led Studies.
Are there specific educational/software requirements needed?
Life Science Degree
Excellent MS Office Skills required
Preferred qualifications
Previous Study Management experience in a similar role
Industry experience
Excellent Project Management Skills
What will be the interview process?
Standard Competency Based Interview
Salary: £311 per day
Location: Uxbridge (office- based role)
Job Type: Contract (6 Month, 7.5 hours per day )
Company Introduction:
Client is a Multinational Biopharmaceutical Company headquartered in California. Client is the world's largest independent biotechnology firm. Client focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. Client has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Main duties for this role:
Track receipt of ISS concepts/proposals from Investigator Sponsor
Facilitate communication with Sponsor via collaboration with TA/Medical staff (eg: acknowledgement of receipt of proposal, provision of scientific comments on protocol)
Complete sponsor qualification process (in collaboration with TA/Medical staff as needed)
Facilitate categorization, review and approval of ISS proposals with medical personnel (including documentation)
Initiate and ensure execution of Confidential Disclosure Agreement where necessary
Facilitate team review process/sign off for proposals, protocols and amendments and submit for re
view by Exec Medical Director/GDL or review committee eg: GPRC, IPRC
Support meetings internally (e.g. GDT, product-specific ISS Review meetings, IMT, NAMT, Finance) and with Sponsor as appropriate (creating agendas, minutes, etc)
Provide protocol submission package including product specific safety information, details of firm’s ISS process and requirements to sponsor for protocol review and start-up activities
Partner with Global /Regional Operations representative regarding drug forecasting including ancillary supplies, clinical trial labelling activities, expiry dates/memos as appropriate
Partner with GCP&P on budget negotiations and ensure conduct of Fair Market Value assessment
Collaborate with GSM to notify Sponsor of any actions or information required from Due Diligence process
Initiate and support the contract execution process in collaboration with legal
Support the collection of ISS Approval Package (ISSAP) documents and forward for signature approval
Enter data (e.g.. milestone tracking, enrolment status) and maintain source systems
Track essential documentation and archive in TMF
Procure updates from the Sponsor regarding enrolment, milestone payments, etc, per contract and initiate and track invoices and payments per contract
Ensure the provision of safety updates to Sponsor in collaboration with Safety
Liaise with external CRO vendors appointed by the sponsor as necessary
Assist Global Operations with product reconciliation and destruction as appropriate
Co-ordinate review of publications as necessary
Support training and co-ordination of local ISS Associates and GCSM staff (regional role only)
Manage direct reports and/or act as mentor to develop Associates/Sr. Associates (where relevant, and excluding LOC staff)
Review ISS metrics, assist with measurement of compliance to process requirements
Communicate ISS status to management as requested
Identify and facilitate resolution of ISS cross-functional issues; lead cross-functional task forces or working groups under supervision of Senior Manager
Requirements:
Experienced CRSM required to project manage Investigator led Studies.
Are there specific educational/software requirements needed?
Life Science Degree
Excellent MS Office Skills required
Preferred qualifications
Previous Study Management experience in a similar role
Industry experience
Excellent Project Management Skills
What will be the interview process?
Standard Competency Based Interview