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eCOA Lead Senior

posted by: spj_bot

About the Job

Excelya is looking for an experienced eCOA Lead Senior to join our innovative team! In this pivotal role, you will take the lead in managing electronic Clinical Outcome Assessments (eCOA) across clinical trials, ensuring that data collection meets the highest standards of quality, efficiency, and regulatory compliance.

As an eCOA expert, you will work collaboratively with various stakeholders to develop and implement strategies that enhance the clinical study experience for participants and investigators alike.

Main Responsibilities

  • Lead the design, implementation, and management of eCOA solutions for clinical trials.
  • Work closely with clinical project teams to deliver eCOA requirements aligned with objectives and timelines.
  • Coordinate the development and maintenance of eCOA systems, ensuring compliance with relevant regulatory frameworks.
  • Provide training and support to study teams on eCOA processes and tools.
  • Monitor eCOA data quality and provide insights for continuous improvement.
  • Collaborate with IT and third-party vendors to optimize eCOA technology and interfaces.

Requirements

About You

We are looking for a passionate individual who shares our values of audacity, care, and energy!

Job Skills

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CMC Project QA manager (Dry forms)

posted by: spj_bot

About the Job

At Excelya, we embody Audacity, Care, and Energy. We are seeking a dedicated CMC Project Quality Insurance professional to join our team, where you will be instrumental in ensuring quality throughout the CMC (Chemistry, Manufacturing, and Controls) processes. This role provides an exceptional opportunity to work in a supportive environment that prioritizes collaboration and innovation.

In this position, you will work closely with cross-functional teams to uphold the highest quality standards for our CMC projects, facilitating compliance with regulatory requirements and contributing to the overall success of product development.

Main Responsibilities

Job Skills

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Information Security Analyst II

posted by: spj_bot

Millennium Health LLC is an accredited specialty laboratory with more than a decade of experience in medication monitoring and drug testing services, helping clinicians monitor the use and misuse of prescription medications and illicit drugs. The testing is used by healthcare professionals to obtain objective information about patients’ recent use of prescription medications and/or illicit drugs and helps monitor the effectiveness of treatment plans.

* Candidate must be local to San Diego and work a minimum of 5 days in the office every 2 weeks.

This individual will be responsible for assisting with information security operations and projects.

The following are intended to be examples of the accountabilities for which the person in this position is responsible.  This position is not intended to be complete or all-inclusive and does not preclude management from assigning other or related functions for which the individual has demonstrated competency through performance.

Job Skills

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Clinical Data Manager I

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Bangalore. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Requirements

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

Experience:  

One or more years as a Data Manager or equivalent combination of education, training and experience

Skills:  Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance

    • Experience in clinical trial databases and applications, clinical data flow, data review, and eCase Report Form design.
    • Understanding of clinical trials and study lifecycle (start-up, maintenance & closeout)

Education: Bachelor’s degree qualification in a Scientific discipline is preferred

Job Skills

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Global Clinical Project Manager Early Phase Oncology

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations/Medical Affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

Job Skills

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Global Project Manager late phase oncology

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations/Medical Affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

Job Skills

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Safety Officer

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work.

We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to join our dynamic and ambitious Pharmacovigilance and Safety team. Rooted in a long-standing tradition of excellence in pharmacovigilance, our department continues to evolve rapidly, offering a vivid, forward-thinking work environment that embraces innovation and growth

Mains Responsibilities :

The position involves performing as Local Contact Person responsible for Pharmacovigilance for Belgium and the Netherlands and participating in local/global projects within the Pharmacovigilance (PV) and Safety department.

Work in several aspects of pharmacovigilance shall be expected, such as

·       Performs local literature search/review or quality control on results, maintain local journal/conference lists

·       handles case reports, complaints, queries (from collection to reporting to Client/Authorities)

·       Prepares/reviews aggregate reports (e.g. PSURs/PBRERs)

·       Prepares Risk Management Plans

·       Assists in handling/monitoring additional risk minimisation activities

·       Maintenance of the PV System

·       Participate in/conduct trainings

·       Participate in audits/inspections

Job Skills

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Documentary System Project Manager R&D

posted by: spj_bot

About the Job

Join Excelya as a Business Expert: Documentary System Project Manager and take a leading role in the transformation of clinical research documentation processes across our organization. You will spearhead initiatives aimed at enhancing our documentary systems, ensuring compliance with regulatory requirements, and improving operational efficiency.

In this strategic position, you will engage with various stakeholders to gather requirements, analyze current processes, and implement innovative solutions that streamline project activities.

Main Responsibilities:

Are you passionate about digital transformation and regulatory excellence in R&D?

We’re looking for a Document Management & Systems Lead to manage and optimize the document management platforms, ensuring high standards of compliance and efficiency.

You’ll act as the bridge between science, quality, and technology, leading key projects that shape the future of documentation in pharmaceutical research.

1) Functional administration:

• Functional administration of the databases

• Follow up of issues and improvements

• Management of evolution and releases as Business Expert

• Follow-up of the system validation status

• Redaction of SOP and training materials

• User assistance

Job Skills

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Senior Medical Writer

posted by: spj_bot

Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

We are seeking a Senior Medical Writer to produce medical writing deliverables (both regulatory and medical communication documents).

Main Activities:

Job Skills

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Key Account Manager

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

As a Key Account Manager (KAM), you will own and grow relationships with some of our most strategic clients in the life sciences sector. You’ll act as a trusted advisor, ensuring client satisfaction, driving revenue growth, and shaping long-term partnerships that matter.

Main Responsibilities

  • Manage 1 to 4 Top-10 client accounts, ensuring strategic alignment and business growth.
  • Serve as the primary point of contact for key stakeholders, building trust and delivering value.
  • Develop and execute annual account plans, including governance, risk management, and growth strategies.
  • Identify and capture cross-sell and upsell opportunities across Excelya’s full service portfolio.
  • Lead business reviews with clients and maintain a 360° view of the account.
  • Oversee contract negotiations, renewals, and master agreements.
  • Collaborate with internal teams (Operations, Business Managers, Marketing, Finance) to ensure seamless delivery.

Requirements

Job Skills

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