Full-Time

Senior Clinical Data Manager

Posted on 9/19/2025

Precision Medicine Group

Precision Medicine Group

201-500 employees

Biomarker-driven clinical development services and consulting

No salary listed

Remote in Spain

Remote

Candidates can be based in the UK, Spain, Hungary, Poland, Romania, Serbia, or Slovakia.

Category
Medical, Clinical & Veterinary (1)
Required Skills
SAS
Requirements
  • Bachelors and/or a combination of related experience
  • Must have at least 8+ years’ experience
  • Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company
  • Must have hands on set up experience
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
  • Able to handle a variety of clinical research tasks
  • Excellent organizational and communication skills
  • Professional use of the English language; both written and oral
  • Experience in utilizing various clinical database management systems
  • Broad knowledge of drug, device and/or biologic development and effective data management practices
  • Strong presentational skills, ability to communicate effectively orally and in writing
  • Strong leadership and interpersonal skills
  • Ability to undertake occasional travel
Responsibilities
  • Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
  • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
  • May perform quality control of data entry
  • Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
  • Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
  • May assist in building clinical databases
  • Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
  • May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
  • Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
  • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
  • Review and query clinical trial data according to the Data Management Plan
  • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
  • Run patient and study level status and metric reporting
  • Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
  • Coordinate SAE/AE reconciliation
  • Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
  • May assist with SAS programming and quality control of SAS programs used in the Data Management department
  • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
  • May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
  • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
  • May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
  • May review Request for Proposals (RFP), proposals, provide project estimates
  • Provide leadership for cross-functional and organization-wide initiatives, where applicable
  • Trains and ensures that all data management project team members have been sufficiently trained
  • Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
  • May present software demonstrations/trainings, department/company training sessions, present at project meetings
  • May require some travel
  • Perform other duties as assigned
Desired Qualifications
  • Experience in a clinical, scientific or healthcare discipline
  • Dictionary medical coding (MedDRA and WHODrug)
  • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
  • Oncology and/or Orphan Drug therapeutic experience
Precision Medicine Group

Precision Medicine Group

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Precision Medicine Group is a life sciences services organization that supports pharmaceutical and biotech companies across the full product lifecycle, from preclinical work to post-launch commercialization. Its offerings are delivered through integrated units like Precision for Medicine and Precision Value & Health, including biomarker assays, cell and gene therapy logistics via Project Farma, global clinical trial management, and regulatory and market-access consulting. The company differentiates itself with an end-to-end, biomarker-centric platform that unites scientific discovery, trial execution, regulatory support, and payer-facing strategy under one umbrella. Its goal is to de-risk and accelerate the development and commercialization of targeted therapies, growing through a mix of organic development and strategic acquisitions.

Company Size

201-500

Company Stage

Growth Equity (Venture Capital)

Total Funding

$310.2M

Headquarters

Bethesda, Maryland

Founded

2012

Simplify Jobs

Simplify's Take

What believers are saying

  • Institute@Precision launched November 2025 positions PMG as biopharma thought leadership hub.
  • 3,500 employees across 35 locations enable geographic diversification in precision medicine markets.
  • 2023 CRO Leadership Awards in all categories affirm expertise for pharma and biotech clients.

What critics are saying

  • Rapid C-suite turnover from Clein to Keegan in October 2024 erodes client trust.
  • Labcorp's April 2024 Fortrea acquisition bundles lab-CRO services, capturing PMG's large pharma clients.
  • Thermo Fisher's 2021 PPD acquisition squeezes PMG's mid-tier positioning with lower-cost scale.

What makes Precision Medicine Group unique

  • Biomarker-driven CRO services integrate Precision for Medicine and Precision AQ across drug lifecycle.
  • Specialty labs in seven global locations deliver rapid biomarker data for advanced therapies.
  • Acquisitions like ApoCell in 2015 and Project Farma in 2020 enhance cell and gene therapy logistics.

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Benefits

Health Insurance

Life Insurance

Disability Insurance

Parental Leave

Paid Vacation

Paid Sick Leave

Remote Work Options

Performance Bonus

Company News

SYMEX ECONOMICS SA
Nov 10th, 2025
Lir Life Sciences Corp. Formerly Blackbird Critical Metals Corp. Announces Closing of Acquisition of Lir Life Sciences Inc.

Lir Life Sciences Corp. formerly Blackbird Critical Metals Corp. announces closing of acquisition of Lir Life Sciences Inc. VANCOUVER, BC / ACCESS Newswire / November 10, 2025 / Lir Life Sciences Corp. (CSE:SKNY) (formerly Blackbird Critical Metals Corp.) ("Lir Life Sciences" or the "Company") is pleased to announce, further to its news release dated August 14, 2025, that it has completed the acquisition (the "Transaction") of all of the issued and outstanding shares of Lir Life Sciences Inc. ("Lir Inc."), and that trading in the common shares of the Company resumed on the Canadian Securities Exchange (the "CSE") on November 7, 2025, under the ticker symbol "SKNY". The Company acquired 100% of the issued and outstanding shares of Lir Inc. in consideration for the issuance of 22,312,678 post-consolidated common shares of the Company to the former securityholders of Lir Inc. In connection with the completion of the Acquisition, the Company also issued 379,000 common shares (the "Admin Fee Shares") to The Back Office Inc., an arm's-length third party, as an administrative fee for services rendered in support of the Acquisition. The Admin Fee Shares are subject to a statutory hold period of four months and one day under applicable Canadian securities laws. The Company is pleased to announce that Dr. Edward Mills has been appointed Chief Executive Officer and as a Director of the Company. Dr. Mills is a globally recognized leader in clinical trials and public health, with over 550 peer reviewed publications in top-tier journals such as The New England Journal of Medicine and The Lancet. Over the past two decades, he has led some of the largest and most impactful clinical trials ever conducted, particularly focused on evaluating treatments for diseases affecting low-income populations. His work has earned him multiple prestigious awards in clinical research. Dr. Mills has raised over $1 billion to support clinical research and public health initiatives and is among the most widely published clinical researchers in the world. He holds a PhD in clinical research and two master's degrees. Formerly Chief Executive Officer of Platform Life Sciences and a Senior Scientist at VirX@Stanford, he continues to pioneer breakthrough therapies. He is also a successful entrepreneur, having co-founded and exited several healthcare companies, including MTEK Sciences (acquired by Cytel) and Redwood Outcomes (acquired by Precision Medicine Group). Dr. Mills will lead the Company's vision around the development of therapies intended to provide accessible obesity treatment through transdermal delivery. The Company also welcomes Mr. Harry Nijjar as Chief Financial Officer and Corporate Secretary. Mr. Nijjar is the Managing Director at Malaspina Consultants and a seasoned finance executive with extensive experience in financial reporting, corporate governance, and strategic advisory across a wide range of industries. He serves as Chief Financial Officer for multiple public companies and has held Chief Financial Officer positions with numerous TSX Venture Exchange and CSE listed issuers. Mr. Nijjar earned a Bachelor of Commerce from the Sauder School of Business at the University of British Columbia in 2010 and obtained his CPA, CMA designation in 2012. The Company also welcomes Dr. Mark Dybul as a Director. Dr. Dybul is a Professor in the Department of Medicine at Georgetown University Medical Center where he serves as Chief Strategy Officer of the Center for Global Health Practice and Impact. He is also Chair of the Board of Purpose Africa. Dr. Dybul has worked on HIV and public health for more than 25 years as a clinician, scientist, teacher, and administrator. He was a principal architect of and ultimately led with the rank of Ambassador at the level of an Assistant Secretary of State, the US President's Emergency Plan for AIDS Relief ("PEPFAR"). More recently, he served as the Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria. The Company also welcomes Mr. Kevin May as a Director. Mr. May is an experienced lumber trader with a deep understanding of the North American lumber market, supply chain dynamics, and sustainable forestry practices. With a keen ability to navigate complex trade relationships, he plays a pivotal role in sourcing and distributing high quality timber products to meet the needs of diverse industries. Before transitioning into the lumber trade, Mr. May built a strong foundation in international relations as a cross-cultural communicator in Japan. This experience honed his skills in negotiation, market analysis, and relationship management, the essential qualities that now drive his success in the highly competitive lumber industry. In connection with the Acquisition, and as disclosed by way of news release on October 29, 2025, Lir Inc. completed a non-brokered private placement of 3,050,270 subscription receipts at a price of $0.35 per subscription receipt (the "Concurrent Financing"), for aggregate gross proceeds of $1,067,594.50. Each subscription receipt automatically converted into one common share of Lir Inc. immediately prior to Closing, and such Lir Inc. shares were exchanged for common shares of the Company on closing. Lir Inc. also settled $109,343 of outstanding debt by issuing 312,408 Lir Inc. shares at a deemed price of $0.35 per Lir Inc. share, (the "Debt Conversion") which were exchanged for common shares of the Company on closing. The securities issued in connection with the Concurrent Financing and Debt Conversion are subject to a voluntary hold period of four months from the date from closing. Prior to Closing, on October 31, 2025, the Company effected a change of its corporate name from "Blackbird Critical Metals Corp." to "Lir Life Sciences Corp." (the "Name Change"). For further information regarding the Acquisition, the Concurrent Financing or the Name Change, please see the Listing Statement of the Company dated November 3, 2025, a copy of which is available under the Company's issuer profile on SEDAR+ at www.sedarplus.ca or on the CSE's website. Lir Life Sciences is focused on researching and developing scalable and affordable treatments for obesity using novel drug delivery methods. The company is advancing a transdermal patch and other novel delivery systems that mimic GLP-1, a naturally occurring hormone that helps regulate appetite and blood sugar. These therapies could potentially offer an alternative to injectable drugs. The goal is to improve access, adherence, and cost-efficiency in both developed and emerging markets. LIR Life Sciences aims to address the global burden of obesity with practical solutions based on established compounds and proven science. Neither the CSE nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. This news release contains statements and information that, to the extent that they are not historical fact, may constitute "forward-looking information" within the meaning of applicable securities legislation based on current expectations, estimates, forecasts, projections, beliefs and assumptions made by management of the Company. Forward-looking information is generally identified by words such as "believe", "project", "aim", "expect", "anticipate", "estimate", "intend", "strategy", "future", "opportunity", "plan", "may", "should", "will", "would", and similar expressions and, in this news release, includes statements relating to the commencement of trading of the common shares of the Company, the financial and business prospects of the Company, its assets and other matters. Although the Company believes that the expectations and assumptions on which such forward- looking information are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that it will prove to be correct. Since forward-looking information addresses future events and conditions, by its very nature it involves inherent risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking information in this news release. The forward-looking information included in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release is made as of the date hereof and the Company undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable laws.

Precision Medicine Group
Sep 15th, 2025
Precision Medicine Group Announces Appointment of Tracey Leahy as Chief People Officer

BETHESDA, MD., September 16, 2025 - Precision Medicine Group (Precision), a leading provider of next-generation drug development, CRO and commercialization services, today announced the appointment of Tracey Leahy as the company's Chief People Officer (CPO), effective immediately.

Contract Pharma
Apr 16th, 2025
Precision Medicine Group Appoints Chief Information and Technology Officer

Precision Medicine Group, a provider of next-generation drug development, CRO and commercialization services, has appointed Eric Hodgins as its Chief Information and Technology Officer, overseeing all the company's technology assets.

PR Newswire
Oct 2nd, 2024
Precision Medicine Group Welcomes Margaret Keegan as CEO

BETHESDA, Md., Oct. 1, 2024 /PRNewswire/ - Precision Medicine Group (Precision), a leading next-generation provider of drug development and commercialization services, today announced the appointment of Margaret Keegan as Chief Executive Officer (CEO) and member of the Board of Directors, effective immediately.

Williston Observer
Sep 12th, 2024
Precision Medicine Group Announces New Chief Financial Officer and Establishes Chief Transformation and Strategy Officer Position

BETHESDA, Md., Sept. 12, 2024 /PRNewswire/ - Precision Medicine Group (PMG), a leading next-generation provider of drug development and commercialization services, today announced the appointment of Karl Deonanan as Chief Financial Officer (CFO), responsible for all finance and accounting functions.

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