Study Manager

Job title:

Study Manager

Company:

House of Talents

Job description

IntroductionScience Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and eagerness to learn are key.
We are very open and communicative go-getters who are keen on results and quality.
To further strengthen our growth, we are constantly looking for new colleagues within Project Staffing.
Working as a consultant equals working with a fixed contract at Science Talents. You get the chance to work on different projects in your field of expertise and gain new experiences in life sciences, the chemical sector, and the food industry.
Work is important; however, we also attach great value to a healthy dose of fun@work! Triggered? Let’s meet!Job descriptionThe Study Manager provides leadership in the execution of clinical trials and serves as the primary contact for the functional groups involved, both within and outside the department, to ensure and facilitate good collaboration across functional areas and works in full compliance with written controlled procedures and applicable law and regulations. The Study Manager performs ad-hoc execution of trial related paramedical tasks (if qualified for the task at hand).

• Provides leadership to the internal clinical study team to ensure successful and timely operational execution of the clinical trial activities, and ensures that study related issues are addressed and resolved;
• Partners with the responsible Investigator in understanding and implementing the protocol to assure safe, efficient, and effective trial execution;
• Reviews and provides input to the trial protocol and informed consent form, and the trial setup in the eSource system;
• Oversees the preparation, review, and approval of the required protocol documentation for filing to the Ethics Committee in compliance with the Standard Operating Procedures, ICH-GCP guidelines and the requirements of the applicable authorities;
• Ensures that the appropriate logistical arrangements for trial materials are made and agreed upon in a timely manner;
• Provides the Business Operations Manager with detailed planning of assessments and tasks (“trial calendar”), including resource and capacity estimation;
• Establishes and maintains a good working relationship with the external partners (e.g., Site Manager, Hospital Pharmacist, Sponsor, etc.) necessary for successful project execution;
• Adequately documents agreements and arrangements made with internal and external partners and ensures that these agreements and arrangements are incorporated and maintained in the clinical trial execution;
• Participates in the review and evaluation of data collected over the course of the trial and actively participates in data visualization meetings to support decisions on dose escalations;
• Reviews, provides input, and qualifies the clinical trial setup in eSource;
• Ensures standard processes are utilized in procedures;
• Is responsible for a trial’s execution, in compliance with the unit’s Standard Operation Procedures, and in compliance with applicable Janssen policies, law and regulations;
• Ensures timely and effective escalation of trial related issues to management, sponsors, and stakeholders;

Other Accountabilities & Tasks

• Is the user of the procedures, and responsible for compliance with the internal quality system. Notifies any violation or deviation to the immediate supervisor or appropriate authority;
• Performs paramedical tasks (if qualified for the task at hand), e.g., assisting in the medical screening of volunteers and patients, catheterizing, dosing, ECG recording, BP measurements, blood drawing, etc;
• Performs laboratory tasks (if qualified for the task at hand), e.g., blood and urine sample processing;
• Provides leadership and direction in developing, improving, and implementing processes and tools to ensure and enhance the department’s efficiency and effectiveness;
• Actively participates in the training and coaching of on-call staff and new and less experienced colleagues;
• Develops productive working relationships with hospital colleagues and with internal colleagues to facilitate the acquisition of studies and to enhance the performance of duties and continued development in the role;
• Establishes good communication and a productive working relationship with hospital colleagues to facilitate collaboration and acquisition of studies from the hospital to the unit.

ProfielMinimum Qualifications / Experience

• A Master’s degree in Science, Biomedicine, Chemistry, Bioinformatics, Healthcare or equivalent through experience
• Experience in project management, scientific or clinical research is an asset
• Licensed Nurse and training and experience in intensive care and/or emergency room nursing is an asset
• Minimum of three years’ experience in the execution of (phase I) clinical studies

Minimum Technical Knowledge and Skills

• Good working knowledge of the ICH-GCP guidelines and other relevant regulatory guidelines and regulations
• Good working knowledge of Basic Life Support;
• Basic knowledge of project management
• Able to apply technical/professional knowledge to the execution of clinical trials
• Fluency in written and spoken English and Dutch
• Computer literate

Minimum Non-Technical Competencies and Skills

• Effective team leader
• Strong organizational, operational and management skills
• Strong written, verbal and interpersonal communication skills
• Able to prioritize and multi-task
• Able to establish and maintain effective working relationships
• Good accuracy and attention to detail
• Results driven
• Pro-active and creative in identifying and solving problems
• Interested in early clinical research, practical medical work and contact with healthy volunteers and patients
• Able to cope with administrative tasks

Other Requirements: Willingness and ability to be flexible with work hours and when necessary to work outside office hours to facilitate protocol requirements and/or to guarantee the safety of the volunteers or patients.OfferWill you become one of us? Join a financially sound company and become part of a group of no fewer than 2,500 top colleagues! We cannot wait to meet you! Fill in the form below and we will reach out to you soon.
contract of indefenite duration, included:

• company car + fuel card

• Health insurance

• Meal vouchers of 8€ per day worked

• Net allowances

• Group insurance

• Smartphone subscription

• end of year bonus (13th month)

• Eco vouchers Apply here

Expected salary

Location

Anvers

Job date

Fri, 14 Feb 2025 00:45:18 GMT

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