Clinical Study/Project Manager-II
PHARMExcel is looking for an engaging and motivated Clinical Study/Project Manager-II to join our growing clinical teams.
You will work at an advanced level to deliver complex clinical trials/ studies (all phases) assigned to PHARMExcel from set up to closeout whilst maintaining and establishing relationships with client teams resulting in client satisfaction, operational excellence and thereby increase potential for repeat business.
You will be accountable to meet the study deliverables and financial performance targets for your assigned studies, including forecasting, revenue recognition, maintaining profit margin and proactively identifying out of scope activities.
You will provide mentorship and support for more junior members of the clinical team and proactively engage in staff development initiatives.
You are required to have 3-4+ years working as a Study/Project Manager (or equivalent role). You will be educated to degree level (preferably in a science related subject) and you will demonstrate extensive knowledge of Microsoft based packages and database applications such as Access and Excel.
In return you will have the opportunity to be part of a dynamic, friendly and growing CRO where employees are at the heart of the organisation.
This is a full-time and permanent position. It is mixture of home and office-based in Hertfordshire
PHARMExcel is an equal opportunities employer.
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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.
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Entry level CTA
PHARMExcel is looking to expand their CTA team. You will work alongside our current CTAs and report into the Senior CTA.
This position is suitable for individuals with a Bachelor’s Degree in Life Sciences, strong organisational skills, excellent written and verbal communication, and working knowledge of computer systems including Microsoft Word, Excel, Outlook, and PowerPoint.
The entry level CTA post will provide administrative support to various projects, by supporting our Clinical Trial Management and Study/Project Management teams, along with maintaining and tracking clinical study documentation, coordinate study materials, and collate relevant study information.
You will be;
- Organised, ability to multi-task, ability to motivate and organise others
- Flexible and proactive approach with a “can do” attitude
- Deliver high quality work
- Willingness to accept and make changes in a fast paced environment
- Able to work independently whilst also being a strong ‘team player’
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