{"id":1142334,"url":"https://alion.io/job/allucent-tmf-lead-india","title":"TMF Lead (India)","company":{"id":7264,"name":"Allucent","domain":"allucent.com","url":"https://alion.io/company/allucent","size_band":null,"is_staffing_agency":false,"is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":{"grade":"A","score":95,"open_postings":12,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":90,"computed_at":"2026-09-24T05:45:00Z"}},"role":"Administrative","role_family":"Administrative","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Chennai, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":14500,"max_usd":42000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":125},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GDPR","optional":false},{"name":"HIPAA","optional":false}],"status":"live","first_seen_at":"2026-09-23T12:51:57Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-09-24T14:08:41Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.\nWe are looking for TMF Lead to join our A-team (remote/hybrid*). As a TMF Lead at Allucent, you are responsible for coordinating the management of trial master files (TMF) for trials at Allucent. This position controls and monitors the activities of the trial team to create, maintain and return to the Sponsor an inspection ready TMF for all assigned studies.\nIn this role your key tasks will include:\nCollects trial specific requirements to ensure the correct set up of the TMF and creation of the study specific TMF plan.\nWorks with TMF Specialists to ensure document metadata entry accurately reflects trial specific requirements and is entered in a consistent manner.\nEnsures that Essential Document Lists are regularly updated by the study team allowing the completeness of the TMF to be accurately assessed.\nOversees TMF document flow in ensure that documents are uploaded within required timelines.\nResponsible for developing cross-functional relationships with internal and external stakeholders to ensure the successful management of the TMF.\nProvides regular status reports to project manager and sponsor regarding the status of the TMF.\nConducts periodic quality reviews of study documents to identify missing documents or poor-quality documents. Where necessary liaises with the document owner to ensure that all findings are addressed in a timely manner.\nSupports audits and inspections to ensure that auditors have access to the TMF, and queries are answered in a timely manner.\nManages TMF to agreed budget and if necessary, discusses out of scope work with the project manager.\nSupports all Allucent staff, by giving feedback and training to effectively assess document quality and manage the TMF.\nDrive completeness, quality and timeliness of TMF content for all assigned studies until close out. \nDraft and contribute as Subject Matter Expert (SME) in the field of TMF lead activities to the evaluation/improvement of processes and procedures within the Quality Management System\nAssure good communication and relationships with (future) clients.\nContribute and take part in client evaluations, visits and bid defenses.\nContribute to other areas of business as required.\nRequirements\nTo be successful you will possess:\nLife science, healthcare and/or business degree\nMinimum 5 years of relevant experience filing documents in the TMF and managing the quality of the TMF.\nMinimum 5 years of experience in drug development and/or clinical research\nGood knowledge of GxP, GDPR/HIPAA and applicable (local) regulatory requirements\nExcellent working knowledge of clinical trial documentation and TMF procedures including the DIA Reference Model\nGood understanding of study documentation and accurate filing acquired from working within TMF groups or other functional areas within CROs or sponsor companies.\nThorough understanding of good document practice and ALCOA+ standards. \nGood analytical skills to understand metrics and identify trends in system reports.\nStrong written and verbal communication skills including good command of English language. \nRepresentative, outgoing and client focused. \nAbility to work in a fast-paced challenging environment of a growing company.\nEffective at problem solving, strategic thinking and conflict resolution.\nBenefits\nBenefits of working at Allucent include:\nComprehensive benefits package per location\nCompetitive salaries per location \nDepartmental Study/Training Budget for furthering professional development \nFlexible Working hours (within reason) \nOpportunity for remote/hybrid* working depending on location\nLeadership and mentoring opportunities \nParticipation in our enriching Buddy Program as a new or existing employee\nInternal growth opportunities and career progression \nFinancially rewarding internal employee referral program \nAccess to online soft-skills and technical training via GoodHabitz and internal platforms\nEligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects \nEligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees\nDisclaimers:\n*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.\n“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”","description_format":"text","description_chars":5075,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Flexible schedule","Growth opportunities","Hybrid work","Professional development"],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Clinical Research","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-09-23T12:51:57Z"}],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":0,"expected_fill_days":90,"reasons":["conf:1","velocity","win:early"],"computed_at":"2026-09-24T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/allucent-tmf-lead-india","json_url":"https://alion.io/job/allucent-tmf-lead-india.json","meta":{"generated_at":"2026-09-24T18:13:46Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}