Clinical Study/Project Manager
A New Year can spark a new change, so come and join a dynamic and ethos driven Company.
PHARMExcel is looking for an engaging and motivated Clinical Study/Project Manager to join our fast growing team. You will take responsibility and ensure all projects assigned are delivered within project timelines and to budget. You are required to have a strong clinical trial management background. Experience of early phase trials would be advantageous along with working outside of the UK.
This is a full-time and permanent position. It is office-based in Hertfordshire with flexibility to work from home (days to be agreed).
To be considered you must have;
Essentials
- 2+ years demonstrated clinical research experience in a pharmaceutical company/CRO/CTU (i.e. study coordinator/study manager/project manager)
- Educated to degree level in science related subject
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Broad knowledge of drug development process and client needs.
- Strong organisational and time management skills
- Excellent interpersonal skills both written and verbal. Ability to confidently communicate with an array of internal and external contacts
- Financial awareness and ability to actively utilize financial tracking systems
- Scrupulous attention to detail
- Ability to work as part of a team and independently in an enthusiastic, pro-active fashion
- Willingness to travel on an occasional basis
- Extensive knowledge of Microsoft based packages and database applications such as Access and Excel
Desirables
- Experience of early phase work
- Familiarity with ISO 14155 and the Medical Devices Directives (as amended)
Download job description
Senior Clinical Quality Assurance Manager
A very exciting opportunity has arisen to join our fast growing CRO. PHARMExcel are looking for a Senior Clinical Quality Assurance Manager (CQA).
As this is a brand new role for the Company you will use your skills and experience to develop the QA department, focusing on continuous improvement,using approved tools, design control, validations, and ensuring adherence to the agency regulations, GxP, Industry Guidelines, local regulations, along with PHARMExcel policies and procedures for the conduct of clinical trials.
You will take primary responsibility for managing the ongoing CQA activities for the Organisation, supporting our Good Clinical Practice (GCP) and Clinical Trial obligations, reporting to the Managing Director.
You will perform Clinical Investigator Site Audits, GCP Document Audits, Internal Process Audits and Vendor/System Audits
You will also lead on any regulatory authority inspection activities.
You will work closely with Clinical Operations, Information Technology, and other supporting areas/ teams, to drive a culture of Quality within PHARMExcel
To be considered you must have;
Essentials
- Minimum degree (BSc) in Life Science or related discipline.
- 5 years + of demonstrated CQA experience in regulated industry such as pharma, biotech, CRO.
- Full understanding of ICH/FDA GCP guidelines, with an extensive knowledge of GCP.
- Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice.
- Understand device regulations, development processes and FDA / EMA/MHRA inspection procedures is also required.
- Experience with effectively managing FDA / EMA/ MHRA inspections, working with regulators and customer audits.
- Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs.
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently
- Ability to work independently.
- Ability to manage conflicting priorities and deadlines
- Ability to negotiate and liaise with clients/vendors in a professional manner.
- Ability to present to staff at all levels.
- Excellent communication, planning and organizational skills.
- Extensive knowledge of Microsoft based packages and database applications such as Access and Excel
This is a full-time and permanent position. It is office-based in Hertfordshire with flexibility to work from home. Competitive salary, private healthcare. Opportunity to work in a vibrant, growing organisation where you can make your mark.
Download job description
Clinical Research Associate-II
A very exciting opportunity has arisen to join our existing CRAs within our fast growing CRO. PHARMExcel are looking for a Clinical Research Associate II who will work across our diverse portfolio providing direct contact with sites to ensure the overall integrity of study implementation, as well as adherence to study protocols.
The successful candidate will be outgoing, vivacious and have the ability to work independently. They will also demonstrate the ability to build strong working relationships with our investigators and site staff.
The key responsibilities for which you will be accountable for include; arranging on-site visits and logistics; establishment of site recruitment plans in collaboration with site staff during Qualification Visit (QV); monitoring completeness and quality of regulatory documentation; performing source data verification (SDV), data collection and drug/device accountability activities; monitoring patient safety on-site and addressing any violations in a timely manner.
This is a full-time and permanent position. It is home based with a requirement to travel to our Head Office in Hertfordshire minimum of 2 days a month.
To be considered you must have;
- Demonstrated experience (2-3years+) of monitoring multiple, multi centre Interventional clinical trials at a CRA-I level (or equivalent)
- Previous experience in undertaking ethics and/or regulatory submissions
- Strong organisational and time management skills
- Excellent interpersonal skills both written and verbal. Ability to confidently communicate with an array of internal and external contacts.
- Scrupulous attention to detail and ability to meet deadlines
- Ability to work as part of a team and independently in an enthusiastic, pro-active fashion
- Willingness to travel as required for monitoring projects assigned (may include international travel)
- Educated to degree level or equivalent (preferably in a science related subject)
- Experience of collecting, handling and tracking data
- Extensive knowledge of Microsoft based packages and database applications such as Access and Excel
- Detailed knowledge of ICH/GCP guidelines, EU Clinical Trials Directives (as amended) and FDA regulations and guidelines (as amended)
Experience of monitoring early phased studies would be an added advantage.
Download job description