Clinical Project Manager
Oversight of all trial deliverables and management of outsourced services to Clinical Research Organisation (CRO) or approved vendors to ensure the smooth conduct and timely execution of our clinical research studies/projects in diabetes and other therapeutic areas of research.
The Clinical Project Manager (CPM) will be the primary point of contact for all assigned studies/ project deliverables as per the scope of work, manage the day-to-day study/project operations including (but not limited to); timelines, budgets, vendors, SOPs, applicable regulatory requirements and ICH/GCP guidelines.
The position will be based in Seville (Spain).
- Responsible for the oversight of outsourced vendor management
- Ensuring clear communication is maintained throughout the study/project.
- Review potential risks in the study/project on an ongoing basis and take action where appropriate.
- Provide regular study/project progress update reports as and when required.
- Assist in the review of submissions to (C) ECs and/ or regional regulatory agencies.
- Manage the resolution of queries raised by (C) ECs and/ or regulatory agencies.
- Implement appropriate actions to ensure the consistency of internal processes to improve efficiency.
- Meet key performance indicators to meet quality and business objectives.
- Participate in internal audits and recommend any improvements on non-compliance to ensure consistency.
- Participate in improving the current IT software systems needed to support functioning of the team and support business needs and filing systems e.g., Microsoft Office, Microsoft Excel
- To oversee, along with the CPD and provide advice on regulatory and administrative issues for study protocols, with an emphasis on the submission and preparation of clinical trial applications for ethics committee and regulatory authorities.
- To work closely with appropriate stakeholders as appropriate to design and develop the study protocol from concept through to submission.
- To have a good working knowledge and maintain awareness of expectations and requirements of ethics and regulatory submissions both in the UK and Europe.
- Ensure adherence to GCP and other rules/regulations as defined by country and regional regulatory agencies.
- To oversee and review safety line-listings provided by the CRO as and when required.
- To maintain the main study tracker to illustrate real-time status of the clinical study/project.
- To ensure the maintenance of the Trial Master File is managed
- Perform co-monitoring visits with CRAs of the partner CRO(s) as required.
- Provide training for team members regarding clinical trial processes and associated regulatory documentation where required.
- Contributing to the development of associated documents including (but not limited to): Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and clinical development representative.
- Contributing to development of clinical outsourcing specifications (as required) to facilitate the bid process and selection of Contract Research Organizations (CROs).
- Managing the interface between CROs and other line functions; ensuring vendors meet quality standards; contributing to the development/amendment of vendor contracts.
- Managing and leading study/project update meetings with CROs and other stakeholders and ensuring all minutes are recorded as appropriate.
- Supporting the forecast and projection of study deliverables including recruitment levels
- Organisation and maintenance of appropriate trial oversight committees as required.
- Uphold their responsibility to adhere to the General Data Protection Regulations
- Liaise directly to Ixaka cross-functional teams independently as appropriate to ensure the smooth running of the clinical study/project.
- To ensure all research conducted by Ixaka is undertaken within the strict confines of Good Clinical Practice (GCP) and the study protocols any deviation from that is managed appropriately.
- To ensure all research undertaken is within the scope of current SOPs.
- To keep training records are maintained and brought to the attention of the CPD if guided training, whether online or face-to-face is needed.
- To ensure, that the patient’s rights, well-being and confidentiality are upheld at all times and that any deviation from this is managed appropriately.
- Provide training to other team members regarding clinical trial processes and associated regulatory documentation where required.
- Delegate tasks to junior staff as appropriate to ensure the consistent management of the study/project.
- A Bachelor’s degree in life science/healthcare.
- Minimum two years’ experience within a clinical project management role.
- Minimum three years’ experience in industry clinical research organisation
- Thorough working knowledge of GCP regulations, pharmacovigilance and appropriate training and certification
- Thorough working knowledge and experience of study start-up, maintenance, close-out and reporting of final clinical study results
- Demonstrable problem solving, conflict resolution, judgement.
- Excellent oral presentation and written communication skills and IT skills
- Proven independent decision making, negotiation and organizational skills.
- Ability to work unsupervised and independently and have excellent interpersonal skills, self-motivation, motivate team members whilst retaining a positive attitude.
- Proven ability in the development and review of SOPs
- Proven experience of managing projects in Advanced Therapies would be advantageous but not essential.
- Proven project management experience
- Fluent in Spanish and high level of English (used to work and communicate in English).
- French is an advantage.
- Willingness to travel nationally and internationally as required.