As a Project Manager at SMS-oncology you have the drive, passion and skills to proactively plan all key events, coordinate all stakeholders and lead a team in an oncology clinical trial setting. As the main line of communication between the sponsor and the project team at SMS-oncology, you ensure team members are well trained and the trial is carried out per contract and within budget. You are flexible, have a can-do mentality and most importantly, you see it as a challenge to exceed client expectations in successfully leading a clinical study.
Role and Responsibilities
- Manage projects in accordance with the contract and proactively recognize any changes in scope
- Act as the main line of communication between the sponsor and SMS-oncology
- Coordinate and conduct feasibility studies, in cooperation with CRA(s)
- Select vendors
- Contribute to the development of study related documents such as research protocols and Informed Consent Forms (ICFs)
- Provide input on study related documents, such as the CRF, publications and clinical study reports
- Set-up the project plan and study team
- Ensure dedicated training of the project team
- Liaise with the project team to ensure that the project is being performed according to study protocol and time-lines
- Prepare progress reports
- Manage the study budget
- Review (pre-)selection, selection, initiation, monitoring and close-out visit reports
- Ensure the Trial Master File is kept up to date
- Provide input to sponsor proposals
- Be on top of trends and (scientific) knowledge within the clinical oncology landscape and drug development market
- May take part in client visits and bid defenses
- Participate in the training of new clinical research staff
- Perform co-monitoring visits
Qualifications and Characteristics of the Ideal Candidate
- Degree in medicine, health care, life sciences or related fields
- At least 5 years of monitoring/CRA experience (preferably in oncology)
- In-depth knowledge of Good Clinical Practice (GCP) and local regulations and processes
- Representative, outgoing and customer focused
- Experience with leading a team preferred
- Excellent organization and management skills
- Good communication skills and administrative excellence
- Fluency in written and spoken English
- Understanding of the Dutch language
- Foreign language skills preferred
- In possession of driving license
- Self-motivated and proactive
What can SMS-oncology offer you?
Our mission is to provide Direction to our clients during the entire drug development path from Drug to Data to Dossier (the so-called “4D” concept). Becoming an SMS-oncology employee allows you to actively contribute to bringing innovative cancer therapies to patients. As a fast-growing dynamic company, we offer exciting opportunities to further develop yourself. We invest in our employees, want them to be happy and secure in their jobs, and to become autonomous, flexible, oncology experts that deliver high-quality work.
If you have any questions or want to apply, please contact our recruitment department at +31 (0) 20 4350 580 or send an email to email@example.com.
Acquisition to this vacancy is not appreciated.