Clinical Data Manager

Proclinical are recruiting a Clinical Data Manager for a biotech organisation. This role is on a permanent basis and is located in London. The client is focused on producing innovative treatments for cancer.

Responsibilities:

• Handle external service suppliers for the delivery of DM milestones to scope, quality, budget, time, resource planning and risk management.
• Supervise data transfers with CROs and third-party data sources, SAE/AE data reconciliation and MedDRA and WHODrug coding.
• Responsible for core data management deliverables which involves eCRF and database design, data quality, data review, and reporting of database / data quality status.
• Guarantee programs meet all GXP/ICH regulations and remain prompt for inspection.
• Assist in database transfer, locking, and filing of clinical study databases.
• Contribute to the development as well as the optimisation of data management SOPs, procedures and initiatives.
• You will assist with cross-functional process definition, novelty and optimisation.
• Other duties may be assigned to this role.

Skills & Requirements:

• At least 5 years of experience in clinical data management within a pharmaceutical organisation or similar science, ideally a small to midsize biotech.
• Know-how of clinical trial data notions, procedures and processes, as well as clinical trial guidelines, industry guidance, conventions and standards.
• Competence in using CDISC standards, SAS, a variety of eDC planforms, systems integrations such as eDC IRT), MedDRA and WHODrug coding.
• Acquaintance with oncology clinical development / drug development in multiple phases of development which involves early phase development.
• Familiarity with efficient external supplier establishments.
• Deliberation, interpersonal and communication skills both verbally and in writing.
• Able to work well with others in a team.
• Know-how of GCP regulations and any other guidelines applicable to clinical trial management.
• An organised individual with the ability to manage priorities and work efficiently while under pressure to meet deadlines.
• Educated to a degree level in a science, medical or pharmacy discipline.
• A driven individual who is focused on business objectives.
• Able to work well independently.
• Solution oriented who is flexible to change.
• Outcomes oriented with a high attention to detail.
• Comprehension of cell and gene therapy.
• Past involvement in regulatory inspections is ideal.
• A fast learner.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at +44 203 854 1033.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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