J&J Family of Companies Functional Manager Early Development & Clinical Pharmacology (ED&CP) in Global Clinical Operations (GCO) in Breda, Netherlands
Functional Manager Early Development & Clinical Pharmacology (ED&CP) in Global Clinical Operations (GCO)
Global Clinical Operations is recruiting a Functional Manager GCO ED&CP for Belgium and the Netherlands. In this position, you will be responsible for:
• The direct functional management of a regional team of ED&CP Trial Managers (TMs), Site Managers (SMs) and Clinical Trial Assistants (CTA).
• Setting goals & objectives for direct reports, performance evaluation, coaching/mentoring, overseeing staff training and development, study assignments, workload distribution and accompanied site visits.
• Feasibility assessment for studies considered to be placed in the region and the development of relationships with key investigators.
• Execution of phase 0, I and IIa clinical studies by direct staff from feasibility assessment to database lock according to protocol, SOPs, regulations and adherence to timelines and budget.
• Evaluating and projecting resource needs for your assigned portfolio in collaboration with other ED&CP Functional Managers and Clinical Program Leaders.
• Recruitment of new staff.
• Developing the capabilities in your region for conducting ED&CP trials from different therapeutic areas.
• Maintaining excellent working relationships with various internal and external stakeholders.
• Providing expertise regarding local health care systems and clinical research regulations
• Participating and/or leading global initiatives as well as driving local (country specific) special initiatives as needed and guiding rollout of new process and procedures.
• Participating in clinical research initiatives with stakeholders from outside the company (i.e., Pharmaceutical Chambers, Medical Societies, Advocacy Groups, Regulatory Bodies, etc.).
• Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 8 years’ experience in the pharmaceutical industry, at a CRO or hospital including extensive clinical research experience.
• Experience in early development and/or clinical pharmacology clinical research is preferred.
• Proven ability of people management
• Strong communication and leadership skills to foster team productivity, talent development and cohesiveness.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
• Flexible and independent mindset with the ability to lead and implement change.
• Strong ability to synthesize and evaluate data generated from various reports and sources.
• Proficient in English language.
• Strong knowledge of MS Office.
• Location: The Netherlands or Belgium
Europe/Middle East/Africa-Netherlands-North Brabant-Breda, Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Janssen Pharmaceutica N.V. (7555)
Clinical Trial Coordination