Associate Clinical Project Management

Associate Clinical Project Management - Leiden, Netherlands

The (Jr) Associate Clinical Project Management is part of the first sub-department and this role will be responsible for management of the MA PMC group's project-related planning, e-archiving of project-related documents and driving cross-functional integration of operational activities, including coordinating across workgroups, facilitating issue identification and resolution and contingency planning. Additionally, this individual will help the Director MA PMC with business planning and meeting planning activities. Finally, this role will provide clinical project management support for ongoing and new research activities (eg Company Sponsored Trials) including planning of contracting, study budget and data display.

His/her activities will include

*Project management and operational support for registry studies (PASS, RWE) and IIS clinical trials,

*Tracking and planning of MA PMC contributions to regulatory related and safety related documents,

*Tracking of all JBV/JBI MA clinical programs,

*Project management and operational support for MA PMC data display activities,

*Maintain MA PMC team folder with up to date project-related information,

*Management of interactions with GCO and the Clinical Project Management staff in US for study conduct and tracking. General responsibilities include

*Developing and maintaining expertise relevant to department's activities,

*Building and maintaining therapeutic area expertise and

*Establishing productive working relationships with the department's key stakeholders.

PRINCIPAL RESPONSIBLITIES

* Provides project management and operational support for observational studies (PASS, RWE) and IIS clinical trials in the immunology therapeutic area. This includes developing and maintaining timelines, facilitating company review and approval process (ReCAP), tracking of studies in the company study repository (JJAR), planning and tracking of contracts and invoices, preparing agenda and minutes for key meetings and tracking overall study progress.

* Develops timelines and tracks all planned and ad-hoc regulatory submission- and safety related- documents involving authorship or review by the MA PMC team. These documents include study protocols and reports, clinical overview documents, health authority response documents, aggregate safety reports (PBRERs, IBs, DSURs,..), RMPs and safety review reports. S/he will develop a timeline with due dates for all planned documents and will add ad-hocs as they come in. S/he will also keep a tracker of all team documents with review/submission timelines, ERIS numbers and health authority assessments as available.

* Keeps updated trackers of all JBV/JBI MA clinical programs with respect to status, budget and data display. He/she will provide regular status updates to the MA PMC Director.

* Provides project management and operational support for JBV MA's data display activities. This will include abstract planning & tracking and publication planning & tracking, as well as facilitating standard procedures for management review through PubStrat

* Organizes and maintains the MA PMC team folder with up to date project-related information.

*Serves as the key contact for MA PMC team's interactions with IPV, GCO and the Clinical Project Management staff in the US for operational aspects of studies, including safety reporting and tracking

* Establishes and maintains good working relationships with key stakeholders responsible for execution of clinical program activities. Holds or participates in regular meetings with all stakeholders

* Develops and maintains expertise on company policies and procedures, as well as applicable national

* Builds therapeutic area expertise related to the company's immunology products and disease areas of interest.

Skills

*Project management skills, high degree of self-organization and attention for detail

* Excellent communication and organizational skills

* Ability to meet deadlines

* Problem solving attitude and early, open communication in case of project issues or major hurdles that may impact the successful trial/project outcome.

* Strong interpersonal skills for negotiating timelines and for effective interactions with international and multidisciplinary members of the organization

* Knowledge of the Immunology field (rheumatology, gastroenterology, dermatology) where biologicals are used. Willingness to build product and disease-state knowledge through independent reading and training provided by the Medical Affairs team members

* Ability to work independently within a remote team without daily supervision

* Previous knowledge of regulatory and business requirements is a plus The Jr. Associate will organize and perform activities as described in this job description, but with daily supervision The Associate will organize and perform the activities described in this job description with a larger degree of independence and/or pro-activity compared with the Jr. Associate, contributing, for example, to the tactical and strategic planning of the department more than the Jr. Associate does.

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.