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At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Clinical Research Manager

Major Tasks

The primary responsibilities of the CRM are to:

• Be responsible for the operational oversight and local project management of OS and IIR from set up to completion.

• Support the development and design of locally sponsored OS, these may be prospective or retrospective (database) studies.

• Lead ethics submissions and ensure regulatory obligations are met, undertake country feasibility assessments, perform site selection and initiation visits, track enrolment activities.

• Ensure site compliance with the study protocol, local regulatory requirements, and all applicable company procedures.

• Where study monitoring is insourced, the CRM will be responsible for undertaking monitoring visits at the investigator site and when it is outsourced the CRM is responsible for supporting the CRO and helping resolve investigator performance issues in compliance with company standards and regulatory requirements.

• Implement processes for managing study budgets including providing monthly accruals and forecasts.

• Facilitate the IIR process by managing meetings, site correspondence, contracts, study finances, payments, drug ordering and distribution.

• Manage external vendors to ensure study and assigned medical affairs projects are delivered to expected quality standards, timelines and budget.

• Collaborate directly with Legal, Compliance, Regulatory and Pharmacovigilance in order to address issues, clarify policies and evaluate study processes, contracts and documentation against legal and regulatory requirements.

• Be responsible for promoting adherence to internal and external compliance standards, including but not limited to the ABPI Code of Practice, GXP, internal Standard Operating Procedures (SOPs), internal policies, regulations and guidelines.

• Have good planning and organizational skills, project or study management skills and demonstrable ability to solve problems related to the implementation of studies.

• Be capable of communicating with investigators, their team members, Clinical Research Organizations (CROs), key internal stakeholders and senior management.

• Effective written and verbal English communication skills, strong oral presentation, interpersonal, decision making and issue resolution skills are required.

Skills, Required Qualifications & Competencies:

• A life science degree or equivalent experience in the healthcare industry

• Broad knowledge of the requirements for clinical trial management e.g. regulatory requirements, IMP management, data management, pharmacovigilance budget development and financial tracking

• Previously completed submissions within IRAS to the various authorities (Ethics Committees, HRA, NIHR, Local R&D etc)

• Experience of site start up, in particular generation of budgets using costing tools and negotiating contracts with universities and R&D departments

• Proven project management skills, including effective planning and organization skills, attention to detail and excellent follow through

• Understanding of the ABPI Code of Practice and GCP or experience in medical affairs and management of key opinion leader activities

• The competency to work effectively with a broad range of clinical research personnel including thought leaders and senior scientists

Location:

United Kingdom : Berkshire : Reading || United Kingdom : Cambridgeshire : Cambridge

Division:

Pharmaceuticals

Reference Code:

786623