Senior Associate Study Management

Position: UK CW Senior Associate Study Management
Salary: £234 per day
Location: Uxbridge
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.

Detailed job description and duties performed:

• 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 review 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 (including milestone tracking and enrolment status) into 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 firm’s review of publications as necessary,
• Support training and co-ordination of local ISS Associates and GCSM staff,
• Review ISS metrics and assist with measurement of compliance to process requirements
• Communicate ISS status to management as requested
• Identify and facilitate resolution of ISS cross-functional issues

Background and competencies required:

• Ability to understand technical, scientific and medical information
• Understanding of drug development process
• Familiar with concepts of clinical research
• Advanced computer skills
• Experience in interactions with outside vendors, e.g., CROs and contract labs
• Experience with administration of site budgets and grants with supervision,
• Experience with development of prospective site-selection criteria
• Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
• Detailed knowledge of Good Clinical Practices (GCP),
• FDA regulations and guidelines, and applicable international regulatory requirements
• Ability to write and present clearly using scientific and clinical issues terminology
• Experience dealing with time demands, incomplete information or unexpected events
• Good organizational and planning skills
• Experience working effectively in a team/matrix environment,
• Ability to understand technical, scientific and medical information,
• Understanding of drug development process,
• Familiar with concepts of clinical research
• Advanced computer skills,
• Experience in interactions with outside vendors, e.g., CROs and contract labs
• Experience with administration of site budgets and grants with supervision
• Experience with development of prospective site-selection criteria
• Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
• Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements,
• Ability to write and present clearly using scientific and clinical issues terminology,
• Experience dealing with time demands, incomplete information or unexpected events
• Good organizational and planning skills
• Experience working effectively in a team/matrix environment

Role to be based in Uxbridge.
Looking for an experienced CTS to join this team in an office based role.