Site Management Service Team Lead - Horsham, United Kingdom - Cmed

Cmed
Cmed
Verified Company
Horsham, United Kingdom

1 week ago

Tom O´Connor

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Tom O´Connor

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Description

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies.

Our offices are located in France, Belgium, Switzerland, Germany, Denmark, Sweden, UK, Romania, US, India and Czech Republic.


The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data.

This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.

We are currently looking for an enthusiastic and talented Site Management Service Team Lead. This role can be home-based anywhere in the UK or EU (where we have the legal entity to hire). Some locations may require a partially remote hybrid in-office schedule.


Core Accountabilities:


The Team Lead, SMS has oversight and management responsibility for Clinical Trial Associates and other members of the Site Management Services Team (all experience levels) regardless of employment type whilst also supporting and being actively engaged in project work and initiatives to support the growth and development of the SMS Department.


Under the guidance of department management, the Team Lead supports position recruitment, supervision, and development of staff as well as ensuring available resources are balanced with contracted obligations and corporate objectives and supports implementation of process and department related improvement for assigned area(s) in addition to being actively assigned to perform and support CTA activities on projects when required.


Principal Responsibilities:

Strategic


Assists with process improvement initiatives across operational unit and in alignment with the CRO to deliver efficiencies and benefits to customers.


Ensures compliance with regulations and industry quality standards and assurance of audit readiness; includes the development of suitable company SOPs and compliance with FDA, EMEA, country specific and ICH-GCP guidelines and representation during audits and inspections.

Leadership and Operational Management


Proactively line manage and develop Site Management Services staff ensuring compliance with GCP ICH Guidelines and adherence to defined budget.


Effectively communicates critical updates and changes with projects on a regular basis, acknowledges employee/project successes and addresses risks to delivery with a focus upon mitigation planning.

Maintains an awareness of company policies and can effectively represent the company perspective to staff.


Supports the development of internal clinical administrative processes, providing input into clinical systems requirements and assists with defining the workflow for systems utilized by assigned employees.

Uses strong communication skills and effective working relationships to ensure consistent quality of work amongst direct reports.

Provides regular reports and updates, as requested.


Ability to perform a hybrid role where role holder will perform Clinical Trial Associate/ Study Start-Up Specialist activities for up to 50% of FTE.

Resourcing and Line Management

Participates in the selection and recruitment of suitable and qualified staff.

Assesses, revises, and improves training processes and requirements for assigned staff to meet changing needs.

Coaches and develops staff for further advancement or enhanced skill development.

Conducts regular 1:1 meetings with staff to discuss performance and study status.

Reviews and approves time and expense entries for nonbillable items only, as applicable.

Collaborates with Clinical Operations management to develop and administer an effective orientation/on-boarding process for new staff.

Additional


The above job description in no way states or implies these duties are the only duties performed by this employee.

The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.


The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.


Essential Work Experience, Qualifications and Knowledge:
Substantial experience in clinical trial administration.

Extensive knowledge of ICH GCP guidelines and industry standards of quality.

Problem solving capabilities with strong attention to detail.

Relationship building skills and strong interpersonal presence.

Excellent written and verbal communication skills.

Ability to balance the needs of the organization with the needs of staff.

Demonstrated ability to lead and motivate a group of clinical research personnel.


Desirable Work Experience, Qualifications and Knowledge:
Bachelor
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