p>Shreeya Patel at CK Clinical is recruiting a Document Review and Maintenance Manager to join a global CRO on a permanent basis. This role is available in a number of locations across the
As a Document Review and Maintenance Manager you will be part of an enthusiastic global service group involved in the delivery of the Global Site Services (GSS) component of assigned studies globally. This position provides an excellent opportunity to be involved in a fast paced department currently experiencing incredible growth.
- Lead the cross-unit coordination of both internal and external, inclusive of sub-contractors, teams involved in the following areas:-
- Document review aspects of Global Site Services deliverables including overall accountability and delivery to time and quality.
- Document collection activities of the Global Site Services (GSS) component of assigned projects during maintenance and close-out including overall accountability and delivery to time, cost and quality
- Masters or University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- Broad knowledge of drug development process and client needs.
- PMP certification.
- Minimum of five years of relevant clinical research/regulatory experience in a pharmaceutical company/CRO including a strong working knowledge of the ICH guidelines, demonstrated skills and experience with review and maintenance of investigator package/essential documentation and demonstrated line management experience.
- A working knowledge of ICH GCP, US FDA regulations, regulations applicable to local office, guidelines, and practices regarding Good Clinical Practices.
- Ability to network, negotiate and liaise face to face and remotely with high level internal and external stakeholders in a professional manner
- Good computer skills with good working knowledge of a range of computer programs.
- Ability to present to staff at all levels.
- Detailed knowledge of financial control procedures (i.e. costing systems, time reporting).
- Ability to resolve project-related problems and priorities workload for self and team.
- Experience in managing projects in a virtual environment.
- Working knowledge of project management processes, especially concerning site maintenance and document review.
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
- Financial awareness and ability to actively utilize financial tracking systems.
- Working knowledge of time and cost estimate development.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
- Excellent communication, planning and organizational skills.
- Ability to negotiate and liaise with clients in a professional manner.
- Demonstrated Regulatory, GMP or QA experience.
How to apply
For more information or to apply for this role, please contact Shreeya Patel on 01438 743047 or email firstname.lastname@example.org Please quote reference CL25687 in all correspondence.