Senior Tmf Classifier

2+ years

Not Disclosed

Bangalore

10 March 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: eTMF Document Classification Specialist
Company: [Company Name]
Location: [Insert Location]

Job Overview:

We are seeking an eTMF Document Classification Specialist to manage document classification under Smart Inbox and ARC review, along with document deletion for clinical studies. This role involves overseeing electronic Trial Master Files (eTMF) for clinical trials, ensuring compliance with regulatory requirements, and maintaining audit readiness. The successful candidate will work closely with key study personnel, ensuring the integrity of the eTMF system and delivering high-quality, compliant documents throughout the study phases.

Key Responsibilities:

Document Management & Classification:
- Manage electronic Trial Master Files (eTMF) for clinical studies, ensuring all Trial, Country, and Site artifacts are classified in accordance with TMF processes.
- Oversee document classification under Smart Inbox and ARC review, and handle document deletion as needed.
- Perform quality checks on e-documents prior to release, confirming image clarity, readability, and accuracy.
- Ensure all essential artifacts are processed and tracked in accordance with company SOPs, sponsor SOPs, GCP, and ICH guidelines.
Audit Readiness & Compliance:
- Maintain the eTMF in a state of audit readiness for quality and compliance.
- Conduct Audit Ready Checks on individual documents uploaded to the eTMF system to ensure proper context and adherence to regulatory requirements.
- Prepare the eTMF for QA or sponsor audits, including resolution of any issues and implementation of corrective actions as needed.
- Participate in internal and client audits as required.
Collaboration & Communication:
- Work closely with team members and stakeholders to identify operational issues and resolve TMF-related challenges.
- Ensure overall client satisfaction by providing high-quality eTMF management throughout the study lifecycle.
- Participate in business improvement initiatives aimed at enhancing quality, productivity, and continuous improvement of business processes.
- Attend internal and external study team meetings as needed and provide training/mentorship to colleagues as required.
Regulatory Knowledge & Training:
- Maintain up-to-date knowledge of applicable regulatory requirements related to TMF management and clinical trials.
- Provide training and mentorship to team members on best practices for eTMF management and compliance.

Qualifications (Minimum Required):

Education:
- Bachelor’s degree in Life Sciences, Business, or a related field.
Experience:
- 3 to 6 years of experience working in a clinical research environment.
- Clear understanding of GCP and ICH guidelines, as well as regulatory and clinical document requirements.
- Proficiency in Microsoft Office, web-based applications, Adobe Acrobat Standard, and related scanning software.
Skills:
- Excellent interpersonal and communication skills.
- Strong attention to detail and organizational skills.

Preferred Qualifications:

Education:
- Master’s degree in Life Sciences, Business, or a related field.
Experience:
- Experience working with clinical electronic systems.

Physical Demands/Work Environment:

Minimal travel (less than 10%) for sponsor kick-off meetings, face-to-face client meetings, or as requested.

EEO & Accommodations:

[Company Name] is committed to diversity and inclusion in the workforce and offers equal opportunities for employment. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, disability, or any other legally protected characteristic. We encourage all qualified individuals to apply.

For more information on how we collect and store your personal data, please refer to our Privacy Statement.

If you require accommodations during the application process due to a disability, please contact: [Contact Email].

Latest Jobs

Medical Science Liaisons (Msl) Director (Biotechnology/Oncology Ne, Ks, Mo, Ar, Region)

Exelixis

Remote

Medical Science Liaisons (Msl) Director (Biotechnology, Oncology, Ca Region)

Exelixis

Remote

Medical Science Liaison (Msl) Director (Biotechnology, Oncology, Ny, Me, Nh, Vt Region)

Exelixis

New York

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Arkansas :

Fort Smith |

Kington :

Frank Scottile Blvd |

Missouri :

Fulton | Milan | St. Louis |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Nebraska :

Hebron | Nebraska City |

Hawaii :

Hilo | Honolulu |

Tennessee :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

Lisbon | Oeiras | Portugal |

WI :

Madison | Wausau |

Republic of Mexico :

Mexico |

northeastern :

New Hampshire |

Oklahoma :

Oklahoma City |

Puerto Rico :

San Juan |

Albama :

Tuscaloosa |

D.C :

Washington |

Delaware :

Wilmington |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Germany :

Germany | GErmany |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Saxony Anhalt :

Halle |

Rotherbaum :

Hamburg |

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Schleswig Holstein :

Kiel |

Berlin :

Mitte |

Mecklenburg Vorpommern :

Rostock |

Saarland :

Saarbrucken |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

Tipperary :

Ballydine |

Cork :

Brinny | Ringaskiddy |

Carlow :

Carlow |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Meath :

Dunboyne |

Dún Laoghaire :

Dún Laoghaire |

Galway :

Galway |

County Dublin :

Swords |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

Pharma Jobs in Canada & Belgium & South America & Greece & New Zealand & Austria & Spain & Philippines & Croatia & Estonia & Vietnam & Italy & Indonesia & Japan & Finland & Korea & Kazakhstan & Thailand & Israel & Remote & Colombia & Tennessee & Romania & Argentina & Egypt & Mexico & United Arab Emirates & Saudi Arabia & malaysia & Ukraine & Peru & France & South Afrcia & Serbia & Czechia & Chile & Bosnia and Herzegovina & Singapore & Bulgaria & Sweden & Taiwan & Poland

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Peru | Argentina |

Brazil :

Brazil | Sao paulo |

Attica :

Koropi | Athens |

Greece :

Greece |

North Island :

Auckland |

New Zealand :

New Zealand |

Austria :

Austria |

Vienna :

Vienna |

Catalonia :

Barcelona |

Madrid :

Madrid |

Cebu Province :

Cebu City |

Philippines :

Manila |

Croatia :

Croatia |

Zagreb :

Zagreb |

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Japan | Saitama |

Tokyo :

Otemachi |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

New Mexico | Ciudad de México |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Paris | Lyon |

South Africa :

South Africa | Midrand |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Senior Tmf Classifier

Job Description

Latest Jobs

Medical Science Liaisons (Msl) Director (Biotechnology/Oncology Ne, Ks, Mo, Ar, Region)

Medical Science Liaisons (Msl) Director (Biotechnology, Oncology, Ca Region)

Medical Science Liaison (Msl) Director (Biotechnology, Oncology, Ny, Me, Nh, Vt Region)

Clinical Studies Spt Coord Iii - Remote

Clinical Scientific Expert - I

Clinical Scientific Expert - I

Site Specialist Ii

Regional Medical Advisor

Life Sciences - Consulting- R&D

Technologist, R&D

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Ireland

Pharma Jobs in China

Pharma Jobs in Netherland

Pharma Jobs in Australia

Pharma Jobs in United Kingdom

Pharma Jobs in England