Clinical Data Manager (remote-based)

Hobson prior has a brilliant opportunity for a Clinical Data Manager to join a biotechnology organisation on a contract basis in Paris, where you will be working remotely. For more information, please get in touch!

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Responsible for initiation, execution and completion of assigned clinical studies within approved budget and timeline.
• Responsible for tracking Clinical Development key metrics including study progress, contracts and budget spend and approval.
• Manage assigned clinical research project(s) according to applicable company Standard Operating Procedures (SOPs) and ensure all managed processes are compliant with internal SOPs and external regulations.
• Ensure that assigned clinical research projects comply with the clinical protocol, the most recent requirements for Good Clinical Practice (GCP) and other applicable regulations.
• Supervise outsourced tasks and services and manage contractor relationships.
• Ensure that regulatory documents are obtained from study sites and that study files are set up and maintained in accordance with GCP and relevant SOPs.
• Any additional administrative tasks as required to support the clinical and medical functions.
• Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research and French regulatory requirements.
• Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality.
• Advise and lead the submissions to the CNOM, EPS and any other regulatory reporting requirements when needed for France.
• Carry out other reasonable tasks as required by the Line Manager.

Key Skills:

• Strong communication skills (verbal and written) to express complex ideas.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Ability to manage multiple priorities within various clinical trials.
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings.
• Ability to set baseline targets, track trends and implement mitigation plans.

Requirements:

• University degree in a health-related field with a minimum of three (3) years direct clinical trial experience in a CRO or research-related organization.
• Previous experience in managing people within a scientific/clinical environment is preferred.
• Knowledge of clinical research process from Phase I through regulatory submission.
• Fluent in both French and English.
• Experience in contract/timeline management preferred with excellent organizational and interpersonal skills.
• Understanding of basic data processing functions, including electronic data capture.
• Working knowledge of current ICH GCP guidelines.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.