TMF Operations Lead Inspection Readiness & FSP Oversight

Madrigal Pharmaceuticals Inc

Madrigal Pharmaceuticals Inc. seeks an Associate Director, TMF Operations, to lead day-to-day TMF strategy, oversight, inspection readiness, and sponsor QC across TMF activities. You will manage FSP resources and drive governance to ensure complete, timely, and inspection-ready documentation. The role requires a strong TMF background, vendor oversight experience, and the ability to coordinate with Clinical Operations, Quality, Regulatory, and study teams. #J-18808-Ljbffr

Apply

Vacancy posted 2 days ago

Similar jobs that could be interesting for youBased on the TMF Operations Lead Inspection Readiness & FSP Oversight in Waltham, MA vacancy

Project Manager - GCP Inspection Readiness
...experienced Director-level GCP Inspection Readiness Project Manager to support... ...partnering across Clinical Operations, Quality, Regulatory, and... ...is not responsible for CRO oversight, TMF review, or BLA submission... ...teams. Key Responsibilities Lead and coordinate GCP inspection...
Suggested
Redbock - an NES Fircroft company
Waltham, MA
2 days ago
Executive Director, Operations Lead
...our shared purpose: leading the fight against MASH... ...scientific excellence, operational rigor, and... ...leadership, strategic oversight, and guidance of Clinical... ...staff on the Regulatory Inspections process and develop a... ...approach for Inspection readiness. Assist the QA...
Suggested
Minimum wage
Full time
Local area
Flexible hours
Madrigal Pharmaceuticals
Waltham, MA
4 days ago
Associate Director, Trial Master File Operations
$179.36k - $205.68k
...our shared purpose: leading the fight against MASH... ...scientific excellence, operational rigor, and... ...Associate Director (AD) TMF Operations will be responsible... ...strategy, oversight, inspection readiness, sponsor QC oversight... ...quality and will manage FSP resources supporting...
Suggested
Minimum wage
Full time
Local area
Flexible hours
Madrigal Pharmaceuticals Inc
Waltham, MA
2 days ago
Head of Operations & Business Management
$109.2k - $174.6k
The Role: The Manager, TMF Systems and Operations plays a key role in supporting the daily operations... ...to ensure accurate, complete, and inspection-ready data and documents throughout the study... ...assigned studies.Serve as TMF Lead sitting on the clinical trial team,...
Suggested
Permanent employment
Full time
Work experience placement
Work at office
Work from home
Moderna Therapeutics
Cambridge, MA
8 days ago
Senior Manager, Pharmacovigilance Operations
..., PV Clinical Trials Operations, the Sr. Manager, PV... ...Operations Functional Lead across Viridian clinical... ...strategy and oversight framework, this role... ...operational execution, inspection readiness, and drive effective... ...Safety Management Plans, TMF Plans, SAE Reconciliation...
Suggested
Work at office
Local area
Immediate start
Remote work
3 days per week
Viridian Therapeutics
Waltham, MA
3 days ago
Director, Clinical Operations Asset Lead (COAL), Late Phase Lung Oncology
...GSK Clinical Operations Asset Lead (COAL), Late Phase Lung OncologyGSK aims to positively impact... ...decisions, vendor selection and oversight of external delivery partners.Provide... ...-level risk management, quality and inspection readiness, embedding Quality by Design principles...
GSK LLP
Waltham, MA
2 days ago
Sr. Director, Clinical Operations
$213k - $280k
...Director of Clinical Operations to lead the hands‑on... ...focus on Phase 1 readiness and execution. The... ...vendor selection and oversight, including... ...standards. Maintain inspection‑ready clinical trial... ..., TMF requirements, clinical... ...(collectively, “FSP”) do not accept unsolicited...
Local area
Metaphore Biotechnologies
Somerville, MA
4 days ago
Head of Operations Management (m/w/d)
$109.2k - $174.6k
The Role: The Manager, TMF Sytems and Operations plays a key role in supporting the daily operations... ...vendors to ensure accurate, complete, and inspection-ready data and documents throughout the... ...assigned studies. Serve as TMF Lead sitting on the clinical trial team, ensuring...
Work experience placement
Work at office
Work from home
Moderna
Cambridge, MA
4 days ago
Director, QA GMP Operations
$188k - $230k
...Facebook.Role Summary:The Director of QA GMP Operations is responsible for management of GMP... .... The Director is responsible for oversight of QA activities and ensuring the... ...compliance. Drive continuous improvement and inspection readiness. Collaborate cross functionally to...
Local area
Dyne Therapeutics
Waltham, MA
8 days ago
Director Program Operations Leader
...Clinical Trial Management Program Operations LeaderAt Regeneron, we use... .... In this role, you will lead operational strategy and... ....Lead vendor selection, CRO oversight, governance activities, and partner meetings.Ensure inspection readiness and lead cross-functional support...
Work at office
Worldwide
Regeneron
Cambridge, MA
2 days ago
Associate Director Clinical Operations Program Lead
$154.4k - $242.55k
...as an Associate Director, Clinical Operations Program Lead based remotely reporting to the Executive... ...-level sponsor’s operational oversight of our strategic partners and other... ...Leads Clinical Operations aspects of inspection readiness activities and acts as subject...
Minimum wage
Full time
Local area
Remote work
Takeda Pharmaceutical Company Ltd
Boston, MA
2 days ago
Associate Director, Clinical Operations Study Lead
$165k - $200k
....Role Summary:The Clinical Operations Study Lead ensures that clinical strategies... ...the selection, oversight, and management of CROs and... ...evaluate completeness of the TMF by performing periodic QC reviews... ...TMF and study is always “inspection ready”Prepare high-quality reports...
Local area
Dyne Therapeutics
Waltham, MA
8 days ago
Clinical Operations Manager
$164k - $199k
...years of clinical operations experience, including... ...trial manager, leading cross-functional teams... ...other regulatory inspection experience is a... ...issuesEnsure inspection readiness through the study... ...Master File (TMF)Manage and oversee... ...for leadership and oversight of the assigned...
Contract work
Local area
Tessera Therapeutics
Somerville, MA
4 days ago
Director, Clinical Operations
$219k - $235k
The Director of Clinical Operations in the Discovery Medicine and Pharmaceutical Sciences... ...planning, operational strategy, inspection readiness, eTMF oversight, vendor management, and continuous... ...and other departmental activities. Lead, mentor, and develop Clinical Operations...
Work at office
Local area
Flexible hours
3 days per week
Alkermes
Waltham, MA
5 days ago
Director Of Clinical Operations
...AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful clinical operations for neuroscience programs, driving... ...in planning, execution, and oversight of global clinical trials with... ...mitigation strategies.Support inspection readiness and compliance initiatives to ensure...
Green Key Resources
Waltham, MA
4 days ago
Associate Director, Trial Master File Operations
$179.36k - $205.68k
...Madrigal Pharmaceuticals seeks an Associate Director of Trial Master File Operations to lead TMF strategy, oversight, and inspection readiness across clinical studies. The role involves managing FSP resources, establishing QC processes, monitoring operational metrics,...
Madrigal Pharmaceuticals
Waltham, MA
20 days ago
Senior Quality Operations Manager
$148k - $180k
...CA office.Position Summary: The Senior Quality Operations Manager provides day-to-day Quality oversight of CMOs, suppliers, contract laboratories, service... ..., audits, quality governance meetings, inspection readiness, and regulatory inspectionsMaintain accurate and...
Full time
Contract work
Work at office
Flexible hours
2 days per week
3 days per week
Ardelyx
Waltham, MA
7 days ago
Biosample Operations Associate
$104k - $125k
...Biosample Operations Associate/Sr. AssociateMenlo Park, California, United States;... ...and chain-of-custody issues.Support oversight of laboratory vendors to ensure compliance... ...-functional stakeholders.Support inspection and audit readiness by ensuring complete and accurate...
Work at office
Remote work
Oruka Therapeutics
Waltham, MA
5 days ago
Director, Clinical Operations
$213k - $240k
...flexible Director of Clinical Operations who has a track record of... ...will successfully lead and optimize activity across... ...Responsibilities:Strategic Oversight & Agility in Clinical Study... ...closureExperience with a submission-ready eTMF, regulatory inspections and/or inspection-...
Contract work
Flexible hours
3 days per week
Oruka Therapeutics
Waltham, MA
5 days ago
Director, Clinical Operations Asset Lead
$189.75k - $316.25k
...disease together. Position Summary The Clinical Operations Asset Lead is the single point of accountability for... ...vendor selection, contracting, and oversight in line with GSK standards Delivery Quality & Inspection Readiness Serve as escalation point for critical operational...
Local area
GSK
Cambridge, MA
1 day ago
CDO Country Cluster Head - US based/remote
$177k - $259k
...The Country-Cluster Lead is a leadership... ...Clinical Development Operations, accountable for the oversight and operational excellence... ...Service Provider (FSP) delivery model.... ...close‐out, and inspection readiness.The role ensures consistent... ...oversight of: + TMF completeness and...
Temporary work
Local area
Remote work
Flexible hours
Ipsen Group
Cambridge, MA
4 days ago
Director/Sr. Director, Statistical Programming
...unmet need. The company’s lead program, DMR-001, is... ...sets the strategy and operating model for programming,... ..., and regulatory readiness of all programming deliverables... ...tools. CRO and Vendor Oversight Define the outsourcing... ...traceable, and are inspection ready. Regulatory...
For contractors
Damora Therapeutics
Waltham, MA
4 days ago
Associate Director, Global Clinical Operations
...Director, Global Clinical Operations Job Title: Associate Director... ...as the global operational lead for assigned clinical... ...particular focus on CRO and vendor oversight, site execution, quality,... ...other functions to support inspection readiness and timely resolution of...
Remote work
2 days per week
3 days per week
Oblenio Bio, Inc.
Lexington, MA
3 days ago
Associate Director, Quality Operations
...Reporting to the Director, Quality Operations, the Associate Director, Quality Operations will lead quality oversight of Viridian’s external... ..., commercial launch readiness, and ongoing GMP readiness... ...readinessAssist with regulatory inspections and internal audits, including...
Work at office
Local area
Immediate start
Remote work
Viridian Therapeutics
Waltham, MA
5 days ago
Staff Operations Program Manager
$134k - $167k
As an Operations Program Manager (OPM) at Boston Dynamics, you will lead cross functional programs and initiatives across our Operations... ...the need for speed with scale readiness, identifying and correcting... ...NPI Program Build Execution & Oversight: Create and maintain build...
Permanent employment
Full time
Visa sponsorship
Boston Dynamics
Waltham, MA
7 days ago
Director, Clinical Quality & Development Operations
$184k - $276k
...Quality & Development Operations (CQDO) Operational... ...leadership and operational oversight of Global Clinical... ...robust processes, inspection readiness, and compliance across... ...junior level staff or FSP employees.As a people... ...include inclusive market-leading benefits to meet our...
Full time
Summer work
Work at office
Remote work
Flexible hours
2 days per week
Vertex Pharmaceuticals
Boston, MA
7 days ago
Associate Director/Director, Clinical Operations Compliance
$175k - $240k
...Director/Director, Clinical Operations ComplianceScholar Rock... ...play a key role in oversight of adherence to... ...ensuring programs are inspection ready.Position ResponsibilitiesEnsure... ...or refinement.Lead initiatives, create process... ...objectives.Develop TMF standards and oversight...
Work at office
Flexible hours
Scholar Rock
Cambridge, MA
3 days ago
Executive Director, Operations Lead
...Pharmaceuticals seeks an Executive Director of Operations to lead clinical trial management and oversee... .... The role requires strategic oversight of study planning, execution, regulatory... ...database locking and regulatory inspection Experience with pivotal, multi-site...
Madrigal Pharmaceuticals
Waltham, MA
a month ago
Senior Director, PV Process Lead
$212k - $333.19k
...Pharmacovigilance (PV) Process Lead: Owns designated end-to-end... ..., accountability, and oversight to ensure consistent execution... ...Assurance, Global Development Operations, Clinical Science, Medical Affairs... ...streamlined, compliant, and inspection ready E2E processes with clear...
Minimum wage
Full time
Local area
Takeda Pharmaceutical Co.
Kendall Square, MA
1 day ago
Head of Operations & Business Management
$115.2k - $201.7k
...Position OverviewAs an Operations Manager in Training,... ...will play a key role in leading and shaping the... ...excellence. If you’re ready to lead, innovate, and... ...execution through detailed oversight of key performance metrics... ...not limited to self-inspections, hazardous waste...
Hourly pay
Full time
Work at office
Flexible hours
Shift work
Night shift
CarMax
Boston, MA
4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to TMF Operations Lead Inspection Readiness & FSP Oversight. Be the first to apply!