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Over de functie
Yacht Life Sciences has a vacancy for an Associate, Clinical Project Management. This is a part-time position for 3 days a week.
As an Associate, Clinical Project Management, your activities will include (1) project management and operational support for registry studies (PASS, RWE) and IIS clinical trials, (2) tracking and planning of Medical Affairs (MA) PMC contributions to regulatory related and safety related documents, (3) tracking of all MA clinical programs, (4) project management and operational support for MA PMC data display activities, (5) maintain MA PMC team folder with up to date project-related information, (6) management of interactions with GCO and the Clinical Project Management staff in US for study conduct and tracking. General responsibilities include (7) developing and maintaining expertise relevant to department’s activities, (8) building and maintaining therapeutic area expertise and (9) establishing productive working relationships with the department’s key stakeholders.
As an Associate, Clinical Project Management, you will report to the Director, Post-Marketing Commitments and Pharmacovigilance. You will have no direct reports.
1. 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.
2. 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.
3. Keeps updated trackers of all MA clinical programs with respect to status, budget and data display. He/she will provide regular status updates to the MA PMC Director.
4. Provides project management and operational support for 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
5. Organizes and maintains the MA PMC team folder with up to date project-related information.
6. 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
7. 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
8. Develops and maintains expertise on company policies and procedures, as well as applicable national and European directives and policies, relevant to the department’s activities.
9. Builds therapeutic area expertise related to the company’s immunology products and disease areas of interest.
- Proven project management skills within the clinical pharmaceutical industry
- High degree of self-organization and attention for detail
- Excellent communication and organizational skills
- Ability to meet deadlines (also under time pressure)
- 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 is a plus
- Previous knowledge of regulatory and business requirements is a big plus
This concerns a part-time secondment position, working 24 hours per week (Attendance on site in Leiden is required on Monday and Tuesday. 1 day working at home is allowed).
Our client is dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases. In their organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. To strengthen their team, they are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to the company.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
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