Specialist, Clinical Trial Admin/Oper

Position SummaryJ&J Medical Device Companies: As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. For more information, visit www.jnjmedicaldevices.com (http://www.jnjmedicaldevices.com).On behalf of the Medical Device Group, under the supervision of the Clinical Compliance Leader, this position is responsible for implementing the clinical compliance process.RESPONSIBILITIES:Support development of Clinical Compliance Plans and perform implementation of compliance activities for assigned projects according to agreed upon timelines.

Conduct Clinical Compliance activities which include, but are not limited to the following:

Support Compliance reviews of clinical trial protocols and associated documentation (including, but not limited to Patient Information Letters, Informed Consent Documents, Patient Questionnaires, CRFs, etc.), as appropriate, to ensure compliance with relevant standards/regulations.

As applicable, review compliance of Study Reports and Publications to prove that the study was performed in accordance with the agreed upon protocol, regulatory requirements and that the clinical study is accurately and completely reported.

Review of Trial Master File to ensure accuracy and completeness of the documentation.

Perform and/or support the implementation of coordinated and comprehensive data-driven compliance activities to ensure compliance with regulatory requirements and SOPs and to ensure a continued state of inspection readiness.

Support Clinical group with preparation, conduct and response to internal and external audits.

Identify problems through analysis of project performance metrics and, with support of Clinical Compliance Leader, recommend corrective and preventive action (CAPA) based on knowledge of applicable regulations; ensure completion of CAPAs generated through internal and external audits.

Support Clinical group CAPA resolution by taking ownership, when applicable, on the corrective and preventative actions.

Effectively engage and collaborate with Clinical Trial Managers/Leaders and other members of the Clinical group, as applicable, to resolve any identified issues/problems.

Participate in or support FDA BIMO audit preparation and execution.

May be involved in other tasks to support Clinical group, as needed.

Participate in Clinical Trial/Study Core Team meetings, as required.

Provide internal communication of important clinical data and events.

Establish themselves as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key stakeholders.

Participate in departmental initiatives across the Clinical group aimed at improving process and efficiency, in particular for the improvement of local processes.

Support Clinical Compliance Leader in ensuring personal and company compliance with all Federal, State, local, and company regulations, policies and procedures for Health, Safety, and Environmental compliance

Participate in project management meetings and provide an overview of clinical quality and workload as needed.

FUNCTIONAL AND TECHNICAL PROFICIENCIES:-Strong skills and proven proficiencies in the following areas are required:Knowledge and understanding of GCP (including ICH-GCP), applicable FDA regulations, EU Directive and ISO 14155

Understanding of quality control application in clinical research.

Knowledge and understanding of the processes involved in conducting a clinical trial

-Excellent Interpersonal, Communication and Presentation Skills

Change Management

Presentation and Influencing

LEADERSHIP COMPETENCIES:

Leadership required in alignment with J&J Leadership Imperatives: Connect, Shape, Lead and Deliver.Connect – develop collaborative relationships with key internal and external stakeholders;

Shape – through process improvements initiatives improve CoE compliance and efficiencies.

Lead – Take ownership for development of self and engage in transparent and constructive conversations.

Deliver - ensure all company sponsored studies are handled according to applicable regulations.

Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

Performs other related duties as required.

QualificationsMinimum Bachelors/University degree with 4-6 years of experience or equivalent required. Master’s with 3 years or PhD/MD/PharmD with 1 years of proven experience preferred.

Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).

Requires understanding and application of GCP regulations and standards applied in clinical areas and medical devices/combination products.

Clinical/medical background - desired.

Requires at least 1 year of Clinical Quality Control/Assurance experience (medical device and pharma - desired, CRO monitoring experience – desired)

Primary LocationBelgium-Brussels-Capital Region-Diegem-Other LocationsEurope/Middle East/Africa-United Kingdom-England-Leeds, United States-Massachusetts-Raynham, United States-California-Irvine, United States-Ohio-Cincinnati, United States-Indiana-WarsawOrganizationJohnson & Johnson Medical Ltd. - fka -Ethicon Ltd. (7355)Job FunctionR&DRequisition ID2105981117W