Job Description

About The Role:

The Investigator Grants Specialist will provide support to project team in managing the payment for investigators and developing the Investigator grant using the standard system such as Grant Plan. This role will be closely working with Project Management and Clinical Operations team to ensure timely delivery of site budget templates and to process site payments every quarter with assistance of project team.

All activities are performed according to the Novotech’s/Client SOP and guidelines. The ideal candidate will be professional, analytical and possess excellent written and verbal communication skills.

Minimum Qualifications & Experience:

• At least 12-36 months of experience in a clinical research organization or equivalent.

• Minimum Batchelor’s degree in Life science or related field

• Experience working in Investigator Payment Process. • Experience working in CTMS/Veeva.

• Experience working in Grant Plan.

• Understanding of Subject Visit Tracking in CTMS.

• Strong hold on excel and Power Point (MS).

• Good communication skills. • Must have analytical, problem solving,

• Excellent verbal and written communication and negotiation skills.

• Excellent interpersonal and relationship building skills.

• Extremely well organized and detailed oriented with demonstrated follow-up skills.

Candidate should have prior background in the pharmaceutical, CRO or healthcare industry. Responsibilities

Responsibilities:

Investigator Payment Activity

• To review, update and track all payments in CTMS appropriately.

• To route correspondence appropriately and ensure all queries raised have been assigned to the correct team member in a timely manner.

• To escalate payment issues/delays appropriately.

• To review payments in line with visit data in CTMS to ensure sites are being paid timely accurate and efficient manner and escalate delays/ issues appropriately.

• Communicate effectively with Project Managers, regarding payment enquiries and managing their expectations accordingly.

• To support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract.

• Assists with maintaining schedule for patient visit payments per contract with the Sponsor and the Site. Process all site payments for patient visits.

• Review the site payment report based on the required due date for payments to be made to make sure the report is correct and free of errors before processing any payments.

• Prepare Investigator Payment report for study status meetings as requested by Project Manager.

• Be accountable for the quality of how each study assigned is set-up and maintained, ensuring payments are correct and that all work carried out is in accordance with Investigator Payment processes and procedures and is audit

• Analyze and assess SVT setup requirement based on study type (simple/complex/cohort).

• Create site SVTs based on CTRAs received from CRAs.

• Setup Master/Site specific SVT templates in CTMS within the required timelines and ensure accurate templates are built in before release to study teams.

• Be aware of and adhere to company processes in areas relevant to Investigator Grant Specialist. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out IGS role.

• Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs.

• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.

Investigator Grants Activity:

• Responsible for the development of investigator grant using industry standard systems.

• Review study protocols work closely with Project Managers to ensure accurate, complete, and timely deliveries of Investigator Grants.

• Candidate will be assigned in the complex projects. Provide initial budget estimates as requested by clients.

• Apply Industry standard of care concepts into building budget model. Address questions related to Fair Market Value.

• Communicate with vendor for system related issues. Manage list of user access to required systems.

• Track finalized budgets and ensured reporting as required.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

Responsibilities

• CDS will perform the responsibilities of the SDMA (refer to job description) to the highest competency and act as both a document uploader and QC reviewer.
• CDS is responsible to liaise directly with the client/alliance partner counterpart (if assigned) with respect to assigned responsibilities.
• CDS will contribute to maintenance and delivery of team Training Programs and serve as a trainer/mentor to new team members.
• Identify, develop and lead potential TMF process improvements which can improve centralised workflows and drive efficiencies across Novotech.
• May undertake line management responsibilities of the DMA team as required to assist the Clinical Operations Management team.
• CDS maintains an understanding of applicable regulatory requirements and changes with TMF Management requirements and keeps Novotech tools and processes updated accordingly.
• CDS may lead the development of the assigned project Filing Plan with Team Lead/Project Manager.
• Involved in assessing overall customer satisfaction for all studies with the central filing function, working with internal and external customers to resolve issues and ensure all SOP requirements are delivered.
• Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance.
• In collaboration with Clinical Operations Management team, assist with review and maintenance of Clinical Operations TMF processes, tools and SOPs as requested.
• Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role.
• Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs.
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.

Minimum Qualifications & Experience:

• Minimum Bachelor’s Degree with concentration in Life Sciences.
• At least 5 years of experience in a clinical research organization or equivalent role.
• Practical experience in handling Trial Master File activities including paper or electronic-TMF (eTMF).
• Prior background in the pharmaceutical, CRO or healthcare industry is advantageous.
• Have good knowledge of eTMF systems.

Novotech is a global full-service clinical Contract Research Organization (CRO).

Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.