Clinical Manager (Cambridge, UK)

 

The Company:
Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering best-in-class drug treatments and services to the under-served rare disease patient community.

We focus on rare metabolic, immunological and neurological genetic conditions. Our patients typically require life-long treatment with life-saving medicine. Frequent and forever drug treatment can significantly impact the quality-of-life of patients. It can also impact the lives of their families and other caregivers. Cycle’s approach is to utilize the latest cutting-edge pharmaceutical technologies to deliver the required medicine, with the minimum impact on daily routines. Just as importantly, Cycle is committed to provide individualized support to patients, families, caregivers and the healthcare professional community. For more information please visit: www.cyclepharma.com

Job Title: Clinical Manager

 Cycle Company:               Cycle Pharmaceuticals Ltd

Location:                            Broers Building, 21  JJ Thompson Ave, Cambridge, CB3 0FA

Position Summary: This full-time position within the Regulatory and Clinical Development department.

Key Duties and Responsibilities:

You will work closely with Cycle’s wider R&D team to:

  • Contribute to the design, planning and implementation of clinical studies, across all phases (PhI-PhIV) but with a particular emphasis for bioequivalence and/or phase I studies, to support the product development and feasibility activities and regulatory submissions in different markets.
  • Interpretation if clinical trial data to support the decision making process for the design of future clinical studies and/or provide support to the regulatory strategy for the assigned products.
  • Work closely with cross-functional departments such as Regulatory Affairs, Quality, Project Management, Commercial, Finance and external Clinical Research Organisations (CROs).
  • Responsible for the management and the delivery of clinical studies, from start up to close down, on-time, within budget and in compliance with ICH GCP, any applicable regulations and Standard Operating Procedure (SOPs).
  • Review of draft clinical trial protocols, informed consents, investigator brochures, monitoring plans/reports, protocol deviations, CRFs, CSRs and other study materials.
  • Responsible for vendor identification, selection, request for proposal, review of contractual agreements for CROs, study monitors, consultants etc.
  • Develop strong and close relationships with the study teams at external CRO acting as account manager for the CRO.
  • Controls study budgets, including forecasting, tracking, and invoice reconciliation.
  • Project manage clinical related activities such as IMP clinical packaging and QP release activities as required.
  • Actively identify, record, track, and develop solutions and mitigations for, risks and issues that may threaten the success of clinical activities.
  • Support the regulatory department in communication with authorities regarding the conduct and the data generated in the clinical studies.
  • Support the quality department in authoring and reviewing SOPs (Standard operating procedure) in relation to GCP, CRO oversight and Clinical Study Management.
  • Responsible for the maintenance of Sponsor’s TMF.
  • Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy.

Qualifications & Skills:

Key Qualifications:

  • Good understanding of product development processes, team dynamics and global clinical trial regulations and GCP requirements;
  • Knowledge of clinical trial operations, from start up to close down across all phases
  • Experienced in CRO oversight/management in a small/medium size pharmaceutical company and/or prior experience in project management/clinical trial management in clinical research industry;
  • Experienced in authoring SOPs in relation to GCP, CRO oversight and Clinical Study Management;
  • Project Management experience in Clinical Trials, use of Microsoft Project is a plus;
  • Bachelor’s degree in a health related/life sciences field (minimum); advance degree is a plus.

Skills:

  • Accurate worker and high attention to detail including when under pressure;
  • Ability to work independently as well as part of a team;
  • High level of prioritisation and organisation to manage a high volume of work and priorities effectively;
  • Result-oriented and takes ownership and accountability;
  • Strong organisational, time-management and communication skills;
  • Enthusiasm and personal initiative to solve problems, a self-starter with ability to work unsupervised.

What makes this role special:

  • Seek to have a profound impact on patients and their families;
  • Work across a range of different disease states;
  • Opportunity for professional development and training;
  • Help shape the culture and future of an emerging pharmaceutical company with a grand vision;
  • Collaborate with a growing team of experienced professionals;
  • Learn from a strong leadership team a with a proven history of

Working Conditions & Environment

The role will be based in our new Cambridge office but some travel to attend meetings may be required. We have an agile working policy which allows for a mixture of home and office-based working, and the flexibility to manage start and finish times around our core working hours.

Employee Benefits at Cycle Pharmaceuticals

In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will be part of the Cycle ‘family’ and enjoy all the benefits that brings:

  • Competitive salary based on experience
  • Performance based bonus
  • Opportunity to join a fast growing and ambitious business
  • Company pension scheme
  • 100% employer paid membership for Private Health Insurance
  • Life and Critical Illness Insurance
  • Corporate Gym membership
  • Regular team building events and an agile working environment

Applications:

Cycle Pharmaceuticals embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Please send us your CV and covering letter
Send an email to careers@cyclepharma.com