Independent Drug Monitoring Manager
Johnson & Johnson
Leiden, Netherlands
35 minuuten geleden

Job Description

Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for an Independent Drug Monitoring Manager to be located in any of our EMEA hub locations like Warsaw, Poland, High Wycombe, UK and add that other locations may be considered based on business needs..

Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time.

From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are handled, interpreted, and prevented.

We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases.

We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.

We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines : the best available treatment at an affordable price.

That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.

Position Overview

As an IDMM you are responsible for the country level and global management of clinical operations activities related to Investigation Product (IP) management for inhouse and outsourced, blinded studies.

The IDMM works closely with the Global Trial Manager (GTL), Clinical Trial Manager (CTM), Global Data Manager (GDM), Trial Supply Manager (TSM) and other Global Development functions during planning, study start up, execution and study closure.

Responsibilities include creating & contributing to development of study procedural documents and system development, oversight for IDM activities with regards to site pharmacy staff training, IP management, IP / dosing-related issues, unblinded Protocol Deviation (PD) escalation and resolutions, and monitoring pharmacy compliance with the protocol and study procedures.

Key Responsibilities

Lead study and IDMM teams in the management of the Independent Drug Monitoring process; including input to and the development of pharmacy related materials forms and manuals) and system set-up and maintenance IVRS and EDC).

Conduct IDM team meetings to discuss study timeline, expected deliverables, and provide study specific (re)training, if applicable.

Oversee the IDM monitoring activities, review IDM monitoring visit reports and ensure investigational product issues are addressed at sites.

Monitor the pharmacy compliance by reviewing system reports, study-specific trackers, and other tools, as needed. Provide pharmacy compliance status, trends, and risks (when identified) to the study team with actions taken.

Investigate urgent / critical unblinded and pharmacy-related issues and coordinate resolutions. Raise to study team in blinded fashion and ensure pharmacy related issues and Protocol Deviations (PDs) are resolved and documented.

Ensure the collection and filing of crucial study documents are completed as per established timelines and / or governing SOPs.

Act as the main point of contact for resolution of any ad-hoc questions associated with IP and IDM issues.

Support the pharmacy / Investigational Product (IP) related inspection readiness activities and provide inputs and follow up on audit CAPAs.

Assisting in Database Locks (DBL) and reviewing unblinded queries, as needed.

Adhere to the applicable SOPs, global regulations, ethics and departmental compliance as determined by GCO management as well as corporate, HCC, and quality guidelines

Qualifications

Minimum of a BS degree is required, preferably in Life Sciences Biology, Chemistry, Biochemistry, Nursing, Pharmacy)

Minimum of 3 years of clinical operations experience in the pharmaceutical industry, CRO or equivalent

Preferred is experience in clinical trial operations within Pharma / CRO.

Experience with clinical trial related activities at the site pharmacy temperature monitoring, drug accountability, pharmacy monitoring)

Understanding of ICH and GCP guidelines

Knowledge of systems / technology IWRS, EDC, etc.)

Excellent organization and time management skills, attention to detail, and ability to multi-task in environment with shifting priorities

Must demonstrate innovative spirit and strong interpersonal and leadership skills

What we’re about :

We are passionate about our work and play vital roles across a range of professional disciplines. We care deeply about our customers and communities.

At Johnson & Johnson our culture enables dynamic and impactful careers! We share a kind of DNA where we’re each :

Committed to caring

Responsible to our communities

Ready to apply our knowledge and know-how

Unique in our background and experiences

The drivers of our own success

Passionate about doing what’s right

Make a unique mark in your career!

If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.

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