Lead the Clinical Trial Team (CTT) including representatives of all operational disciplines involved in the conduct of trial (i.e., CRAs/CROs, Data Management, Pharmacovigilance, Clinical & Exploratory Pharmacology Sciences, Biostatistics, Pharmacokinetics, Clinical Supplies, and other relevant departments, platforms or units).
Manage the study according to Good Clinical Practices (GCPs) and local and/or national regulations, with responsibilities on product and project level.
Collaborate with team members on a day-to-day basis; in particular, build a strong collaboration with the study Data Manager (DM) and the Clinical Study Director (CSD).
Develop and coordinate the study budget, including invoice validation.
Manage CRO/study sites. Escalate quality issues and delays in deliverables, propose solutions, request and ensure follow-up actions. Assess CRO performance by completing CRO post services assessments.
Oversee site visits (Site Initiation Visit, Interim Monitoring Visits, Closure Visit) including in-house preparation such as data listings review.
Participate to the mentoring and training/coaching of Associate CTMs, apprentices or trainees.
Qualifications/Education & work experience
Master's degree education.
5+ years Clinical Research experience within a matrix organization (general understanding of R&D processes including the principals of study design and execution).
3-5 years Field Monitoring experience or related experience - required.
3-5 years Clinical Trial Management or Project Management experience.
Previous Phase I experience - preferred.
Knowledge of and understanding of medical terminology and GCP/ICH guidelines.
Ability to effectively collaborate with scientists, managers from various disciplines as well as external partners in an international and multicultural environment.
Experience with management of outsourced activities.
Strong interpersonal and communication skills.
Results driven, goal oriented, self-motivated, organized, flexible team player with attention to detail.
Knowledge of data management activities. Experience with various computer systems/databases and willingness to learn about new systems/databases.