الصفحة الرئيسية الإمارات العربية المتحدة Clinical Doent and Trial Master File TMF Specialist
الصفحة الرئيسية الإمارات العربية المتحدة Clinical Doent and Trial Master File TMF Specialist
Clinical Doent and Trial Master File TMF Specialist
تفاصيل الوظيفة
Alentis Theutics is a clinical-stage biopharmaceutical company developing breakthrough treatments for cancer and fibrotic diseases. Tasks Expanding and leading the company documentation handling and filing processes across functional areas (e.g., Clinical, Legal, Finance). Handling, filing and tracking of final documents in the company documentation management system. Leading the completion of the study specific sponsor TMF Plan and review of the CRO TMF plan and index in association with the TMF Owner. Overseeing the set-up, maintenance, and archival of the study Trial Master File. Performing quality control (QC) review of documents to be filed in the sponsor documentation system as well as in the CRO eTMF in accordance with standard operating procedures (SOPs), DIA TMF Reference Model and study specific TMF Plans. Conducting periodic oversight QC of the CRO's TMF to identify documentation gaps and quality issues and to initiate corrective actions. Acting as the point of contact for audits/inspections related to the Trial Master File processes and activities and assisting with the development of corrective action plans related to Trial Master File findings. Serving as TMF Subject Matter Expert to study teams and external partners. Ensuring effective communication cross-functionally and issue escalation across TMF stakeholders. Conducting all activities in compliance with Client and CRO SOPs and other regulatory guidance documents. Creation and maintenance of trial budget reconciliation tools. Filing and tracking of invoices from vendors/consultants including oversight of investigator payment process. Creation and maintenance of legal document tracking tools e.g. CDAs, MSAs, workorders etc., and filing of final legal documents in the companies document management system. May support the completion and maintenance of public registries in collaboration with Clinical or Business Development team leads. Performing other activities as assigned. Adhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP, applicable regulations and SOPs. Requirements Bachelor's Degree required in science/health-related field. 5+ years working experience in the biotech and pharma industry. A minimum of 3 years experience with electronic Trial Master Files (eTMF) solutions (Veeva Vault Clinical, PhlexTMF other eTMF platforms) is a must. Solid experience with the DIA TMF Reference Model, ALCOA+ standard and document management best practices is mandatory. Broad understanding of records management requirements in Drug Development. Experience performing Quality Control of TMF documents and CRO oversight QCs. Experience supporting audits and regulatory inspections. Familiarity with various aspects of clinical trials and regulatory requirements for clinical trials (ICH/GCP, FDA, EU-CTR). Basic understanding of the clinical trial budget and reconciliation process is an asset. Pro-active attitude, acting with sense-of-urgency and applying an entrepreneurial mindset. Ability to think analytically, identify problems as they are occurring (proactive management), and rapidly identify and implement solutions that are GCP compliant. Excellent organizational and planning skills, including strong attention to detail. Strong interpersonal skills. Ability to collaborate effectively with the study team, cross-functional team members and external partners (CROs, vendors). Excellent communication skills. Proficiency in English (written and oral). Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland.
#J-18808-Ljbffr Bio & Pharmacology & Health
Apply safely
To stay safe in your job search, information on common scams and to get free expert advice, we recommend that you visit SAFERjobs, a non-profit, joint industry and law enforcement organization working to combat job scams.
الشركة المعلنة عن الوظيفة
Confidential
Similiar Jobs that might interest you
Contracting & Procurement Specialist
NES Fircroft... of Contracting & Procurement Specialist Position: Contracting & Procurement Specialist Location: Dubai On Contract ...
الإمارات العربية المتحدة 5 أيام مضت
Supply Chain Specialist
NES Fircroft... . Position: Supply Chain Specialist Location: Abu Dhabi, UAE ... with the below: Procurement Category Management Supplier ...
UAE - Abu Dhabi 5 أيام مضت
Senior HSE Specialist
PETROPLAN... are seeking a Senior HSE Specialist to join the Major ... be a full time, permanent contract job, offering a competitive ...
UAE - Dubai 5 أيام مضت
Senior HSE Specialist
PETROPLAN... are seeking a Senior HSE Specialist to join the Major ... be a full time, permanent contract job, offering a competitive ...
UAE - Dubai 5 أيام مضت
Sr. Accounts Payable and Inter Company Accountant
NES Fircroft... Company Accountant Location: Dubai, UAE Contract Duration: 6 months, renewable - exclusive ...
UAE - Dubai 5 أيام مضت
Sales and Billing Clerk
NES FircroftWe have an opportunity with one of our reputed client in UAE. Position: Sales and Billing Clerk Location: Abu Dhabi, ...
UAE - Abu Dhabi 5 أيام مضت
Digital Well Program and Real Time Well Engineering
NES FircroftWe have an opportunity with one of our reputed client in-UAE. Position: Digital Well Program and Real Time Well ...
UAE - Abu Dhabi 5 أيام مضت
Geologist
SofomationAdvance graduate level degree (minimum Masters level) in Geology, preferably with a PhD Minimum 15+ years of Oil ...
UAE - Abu Dhabi 5 أيام مضت
Architectural Engineer Level II
NES Fircroft... Abu Dhabi (UAE) Contract: 1 Year & ... , specifications, drawings, schedules, contract documentation and the like. ...
UAE - Dubai 5 أيام مضت
Mud Engineer
Confidential... Summary: The Mud Engineer (HPHT Specialist) is responsible for designing, managing ...
الإمارات العربية المتحدة 5 أيام مضت
Project Engineer
NES Fircroft... Contract Duration: 12 months, renewable -Long term contract ... manage contract negotiations in cooperation with contract ...
UAE - Dubai 5 أيام مضت
Senior HVAC Designer
NES Fircroft... HVAC Designer Location: Dubai (UAE) Contract: 10 Months 5 Days working ...
UAE - Dubai 5 أيام مضت
Senior Civil Designer
NES Fircroft... HVAC Designer Location: Dubai (UAE) Contract: 10 Months 5 Days working ...
UAE - Dubai 5 أيام مضت
Job Opportunities for Middle East
SofomationPosition : Lead Reservoir Engineer Bachelor's degree in Reservoir Engineering/Petroleum Engineering. Minimum 15 years ...
الإمارات العربية المتحدة 5 أيام مضت
... for a 12 month renewable contract. A professional Reservoir Engineer with ...
UAE - Dubai 5 أيام مضت
Accounts Payable Accountant
NES FircroftHello, Greetings from NES Fircroft !! We have an opportunity with one of our reputed clients in Dubai for the position ...
الإمارات العربية المتحدة 5 أيام مضت
Management Accountant
NES FircroftHello, Greetings from NES Fircroft !! We have an opportunity with one of our reputed clients in Dubai for the position ...
الإمارات العربية المتحدة 5 أيام مضت
Hello, Greetings from NES Fircroft! We have an URGENT role with one of our reputed client in UAE. Position: Operations ...
UAE - Abu Dhabi 5 أيام مضت
Coord, Real Estate Project
HalliburtonWe are looking for the right people - people who want to innovate, achieve, grow and lead. We attract and retain the ...
UAE - Dubai 5 أيام مضت
لماذا تقوم بالإبلاغ عن هذه الوظيفة؟
Job has expired لا يمكن عرض هذه الصفحةبدلًا من ذلك، يمكنك النقر على الرابط أدناه أو نسخ/لصق الرابط في متصفح الإنترنت الخاص بك.
https://en-ae.whatjobs.com/coopob__cpl___411_1714470__2112?utm_source=2112&utm_medium=feed&keyword=Clinical-Doent-and&location=Dubai&geoID=3