The Clinical Document Specialist (CDS) will provide support for Trial Master File (TMF) activities to the clinical teams for assigned projects
This role will be responsible for the overall management and quality maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the Trial Master File (TMF) The CDS will have a strong focus on ensuring routine document management operations are performed with adherence to otech SOPs This role to manage Trial Master Files (TMF), both electronic and paper in format according to project requirements, ICH GCP guidelines, local/global regulatory requirements and otech/Client SOPs
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
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 otech s/Client SOP and guidelines
The ideal candi will be professional, analytical and possess excellent written and verbal communication skills
Minimum Qualifications & Experience:
At least 12-36 ths 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 de strated follow-up skills
Candi should have prior background in the pharmaceutical, CRO or healthcare industry
Responsibilities
Responsibilities:
Investigator Payment Activity
To review, up 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 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 otech policies and be mindful of the role of otech 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 otech 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
Candi 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 ket Value
Communicate with vendor for system related issues
Manage list of user access to required systems
Track finalized budgets and ensured reporting as required
otech 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
