Niki De Vink - Bär Email & Phone Number

Zeist, Utrecht, Nederland

Providing strategic direction and leadership to the Regulatory department. And to coordinate, manage and execute the (inter)national clinical regulatory and EC submission and approval process within a clinical project, to gather regulatory intelligence and to establish regulatory strategies, and to advise and support clients and project teams regarding the applicable requirements and processes.Responsibilities:* Coordinates the activities of the Regulatory team, identifies capacity problems in respect of the individual- and team workload and allocates resources to (clinical) projects; * Departmental budget control; * Complies with and monitors the project and departmental budgets; * Provides regulatory strategy for (clinical) projects at request; * Acts as line manager for the Regulatory staff, including team goal-setting, coaching and encouragement of development; * Gains and maintains knowledge of (inter)national clinical regulatory legislation and requirements; * Provides input to proposals and bid defences on regulatory submissions activities;* Acts as a liaison between the review committees, regulatory agencies, Local Partners, vendors and the client to ensure that protocols are approved, and that supplementary information is provided in a timely manner as requested; * Ensures a high level of quality of the clinical trial submission processes by performing Quality Control activities; * Ensures (local) activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards; * Performs progress reporting to stakeholders; * Identifies and assesses regulatory risks and related project issues and makes recommendations to stakeholders; * Contributes to process improvements, e.g. professionalization of work activities, methods of reporting, implementation of new legislation and regulations; * Assures compliance of general and study-specific regulatory processes with (inter)national law and regulations.

Zeist, Utrecht, Nederland

Coordinating, managing and executing the (inter)national clinical regulatory and EC submission and approval process within a (clinical) project, to gather regulatory intelligence and to establish regulatory strategies, and to advise and support clients and project teams regarding the applicable requirements and processes.Responsibilities:* Coordinates the activities of the Regulatory team, identifies capacity problems in respect of the individual- and team workload and allocates resources to (clinical) projects;* Assists in departmental budget control;* Complies with and monitors the project and departmental budgets;* Provides regulatory strategy for (clinical) projects at request;* Acts as line manager for the Regulatory staff, including goal-setting, coaching and performance evaluation;* Gains and maintains knowledge of (inter)national clinical regulatory legislation and requirements;* Develops and maintains a regulatory training plan for all stakeholders involved;* Provides input to proposals and bid defences on regulatory and ethics submissions activities; * Creates a regulatory and EC submission and approval plan at the start of a project;* Acts as a liaison between the review committees, regulatory agencies, Local Partners, vendors and the client to ensure that protocols and supplementary information are approved in a timely manner as requested;* Ensures a high level of quality of the clinical trial submission processes by performing Quality Control activities;* Ensures (local) activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards;* Performs progress reporting to stakeholders;* Identifies and assesses regulatory risks and related project issues and makes recommendations to stakeholders;* Contributes to process improvements;* Assures compliance of general and study-specific regulatory processes with (inter)national law and regulations.

Zeist, The Netherlands

In my role as Clinical Regulatory Manager at Julius Clinical, I built the Regulatory department. Prior to my tenure, all regulatory tasks were handled by the Project teams. Upon joining, all regulatory activities transitioned to the Regulatory department under my supervision.Managing the (inter)national clinical regulatory and EC submission and approval process within a clinical trial and to advise and support clients and project teams regarding the applicable requirements and processes.Responsibilities:* Gains and maintains knowledge of (inter)national clinical regulatory legislation and requirements;* Creates and maintains a database with up-to-date information on ongoing and completed trials;* Develops and maintains a Regulatory training plan for all stakeholders involved;* Provides input to proposals and bid defences on regulatory and ethics submissions activities; * Creates a regulatory and EC submission and approval plan at the start of a project;* Acts as a liaison between the review committees, regulatory agencies, Local Partners, vendors and the client to ensure that protocols are approved and that supplementary information is provided in a timely manner as requested;* Ensures a high level of quality of the clinical trial submission processes by performing Quality Control activities;* Ensures (local) activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards;* Performs progress reporting to stakeholders;* Identifies and assesses regulatory risks and related project issues and makes recommendations to stakeholders;* Assures compliance of general and study-specific regulatory processes with (inter)national law and regulations.

Zeist, The Netherlands

Ensuring delivery of the assigned project(s) on time, on budget and meeting regulatory requirements and customer expectations. This is achieved through an efficient planning, coordination and financial management of (complex) (multi)national clinical projects in accordance with the protocol, SOPs, WI’s/Policies, applicable laws and ICH-GCP guidelines.Responsibilities:* Starts up and manages clinical trials with all relevant guidelines, legislation and SOPs; * Oversees a team of CTLs and/or functional project leads;* Ensures all relevant study specific documentation is developed in a timely manner;* Monitors and manages the progress of the clinical trial against the project plan and previously defined performance indicators in terms of quality, quantity and budget and adjusts implementation as necessary; Is able to have effective discussions with customers to resolve study complex or high impact study challenges;* Ensures a robust risk management plan is in place and collaborates closely with the overseeing PD to ensure all relevant stake holders are involved and held accountable;* Reports the progress made to the customer, the next level internally, the MT and other relevant stake holders;* Acts as point of contact for the customer on tactical and strategic level, and for other PMs as assigned to the project;* Contributes to process improvements, e.g. professionalization of work activities, methods of reporting, implementation of new legislation and regulations;* Accountable for the project finances in accordance with the customer contract and the budget:- Negotiate and agree budget or changes to budget with customer- Assist in completion of / check Unit-based Spreadsheets- Assist in completion of / check monthly forecasts- Adequate analysis of project performance sheets and escalation to Departmental Heads and MT- Manages the project margin and identifies opportunities to maximise project profit margins.

Zeist, Netherlands

Managing clinical monitoring and site management activities of trials in one or more countries and to provide training and coaching for the CRA teams in the assigned countries with regard to protocol, Case Report Forms and study-specific procedures.Responsibilities:* Manage the clinical activities in the assigned countries in accordance with previously defined performance indicators in terms of both quality and quantity and implements actions as necessary;* Monitors the clinical activities in accordance with protocol, SOPs, applicable laws and ICH-GCP guidelines;* Ensures that information is conveyed effectively between the sponsor, Project Manager and the CRA team;* Reviews monitoring visit reports;* Responsible to perform and coordinate all aspects of the clinical monitoring process for 1 or more sites;* (Contributes to the) development of study-specific documentation/processes (in cooperation with the Project Manager, Quality, Training and Compliance department;* Trains CRAs with regard to protocol, Case Report Form (CRF) and study-specific procedures. Perform accompanied site visits;* Ensures the correct query process is followed in collaboration with Data Management;* Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions;* Supports the CRA team during inspections by healthcare authorities or audits;* Ensures the reliable documentation and archiving of study documents, both at the study site and 'in-house’;* Supports PM with managing project budget.

Gouda, The Netherlands

Responsible for the operational conduct of clinical trials in European countries; Supporting local monitoring teams in site management during initiation, monitoring and close-out visits with emphasis on maintaining consistency across clinical study sites; Coaching (junior) CRA's; Budget and contract negotiations; Making sure that the study is done according to the international and local law and regulation and according to the SOP’s.

Gouda, Netherlands

Coaching (junior) CRA's; Responsible for setting up, developing study documents (e.g. CRF),coordinating and accompanying clinical research in Dutch hospitals; Making sure that the study is done according to the international and local law and regulation and according to the SOP’s; Responsible for obtaining and maintaining approval from the Ethic Committee(s) and Competent Authorities which is needed for performing research in the Netherlands; Budget and contract negotiations; Selecting clinical trial sites for (new) studies; Initiating a new study in a clinical trial site; Monitoring data during a visit at the clinical trial site; Making sure that a proper closure is done at the clinical trial site at the end of the study.

Gouda, The Netherlands

Almere, The Netherlands

Gouda, The Netherlands

Gouda, The Netherlands

Preparation and development of policy in the field of health and well-being. Advisor of line-management concerning health issues.

Gouda, The Netherlands

Project management, coordinating project teams, starting and conducting health promoting activities.

Msc, Health Promotion

Health Promotion

- Research assistant of a study on prevalence of asthma among 40.000 schoolchildren in Houston. - Attendance of a health promotion course.

Havo / Vwo

Activities and Societies: Helping students with their homework during the last 3 years at school.