Clinical Team Manager – Senior

📋 Description

• Assume responsibility for coordinating clinical monitoring activities, managing the CRO clinical/site management functions, and co-monitoring the assigned Phase I clinical studies in compliance with regulatory mandates, Good Clinical Practice (GCP) guidelines, and Standard Operating Procedures (SOPs) to uphold the highest standards of quality, timely delivery, and budget adherence, aiding in the achievement of Clinical Development goals and clinical excellence.

• Ensure coordination and oversight of clinical activities.

• Facilitate efficient and comprehensive study initiation by supervising the Clinical team of the CROs and collaborating closely with other pertinent team members involved in the study setup (DM, regulatory, CMC, etc.); ensure feasibility reports are thorough.

• Evaluate site feasibility reports in alignment with the oversight plan, assist the Clinical Project Manager (CPM) in site selection, confirm the timely gathering of essential study documents, including regulatory and ethics committee materials for submission, while ensuring that all setup activities are completed prior to each site initiation as per the oversight plan.

• Validate the final clinical study documents (such as the study manual and monitoring plan) prepared by the Clinical CRO.

• Assist the Clinical CRO in training the Clinical Research Associates (CRAs) on all study-specific operational tasks and engage in the organization and preparation of monitor and investigator meetings alongside other study team members (Corporate and/or affiliates, CROs as appropriate).

⛳️ Requirements

• A graduate in life sciences or medicine, or possess other relevant qualifications.

• Minimum: CRA certification.

• Relevant experience in pharmaceutical drug development: At least 1 year (preferably 2 years) as a Lead CRA, coordinating clinical activities/site management for the setup and execution of international registrational studies (across multiple sites/countries).

• A minimum of 3 years of experience as a Field CRA monitor, either in CROs or the Pharma Industry.

• Experience in Phase I Oncology.

• Strong understanding of Good Clinical Practice (GCP) and ICH regulations.

• Proficient in preparing clinical study documentation for study setup, maintenance, and closure.

• Skilled in managing and nurturing relationships with Contract Research Organizations (CROs).

• Experience in global studies (across multiple countries/sites).

• Previous experience in therapeutic areas such as Neuroscience, Oncology, or radiopharmaceutical compounds is advantageous.

• Proficient in English at a strong intermediate level.

🏝️ Benefits

• Flexible work arrangements.

• Opportunities for professional development.