We Value All You Do
We are fully committed to attracting and retaining the right people. Aptus values its staff, should you work with us we offer flexible working conditions. In a spacious modern office and are willing to provide training when needed. We are a growing company looking to the future and are always looking for exceptional clinical development experts.
Why work with us?
Aptus are a medium sized Full Service Clinical CRO passionate about creating great opportunities for its employees be that desired training or progression opportunities.
Joining Aptus presents the opportunity to develop with your role whilst becoming point of a passionate team of specialists with a common goal of supporting clients in progressing their medicines to the next stage, and ultimately ensuring these therapies become available to patients in the future.
Building a CRO clients and employees can trust. Focusing on Accountability, Pride, Trust, Uniting people and Supporting communities.
Over the last year I’ve absolutely enjoyed working with each and every one of you. Thank you for believing and trusting me with your projects and clients.
Working on the study has been a great highlight for me and despite the challenges, we’ve arose with resilience and delivered with excellence. Clients may or may not say it often enough, but I can attest to this as I’ve watched every team member excel with a positive attitude. To Louise who has been an amazing line manager, a great support and cheerleader. I have nothing but good things to say about Aptus Clinical, its work ethic and leadership. I truly believe that Aptus Clinical will continue to soar to great heights.
The Best Place I Have Ever Worked
I worked at Aptus for 9 months on a project and I can honestly say it was the best place I've ever worked at. They treat you like adults and respect you. They are really flexible regarding working as long as you get your hours done in the week! You are made to feel like a valuable member of the company, and I'm truly grateful to have worked there. Hoping to go back in the future!
There is a real sense of family and belonging at Aptus, and I am proud to be part of this great company.
I enjoy the diversity of the work at Aptus, it's always interesting and we work with some great clients The company places real value on the experienced team that they employ and are supportive and forward thinking. Working at Aptus enables me to have a good work/life balance.
The environment is friendly and supportive a great place to work.
I love working with so many hard working and diligent colleagues in a fantastic environment, with a positive culture. The work is always interesting and diverse. I have been working for Aptus for six years and during that time they have been supportive and flexible to enable me to have a good work/life balance.
New Roles in a Growing Team
Our Site Activation Managers (SAMs), based in Europe, are primarily responsible for the identification and activation of clinical sites and acting as the study functional lead for the Central Site Services team. The SAM works directly with the Project Manager, Clients, Vendors, and other internal functional teams to ensure quality deliverables on-time and on-budget. Our mission is for our Catalyst staff to operate seamlessly with our customer teams using the Catalyst site centric model to enhance employee satisfaction while giving the sites and customers the reassurance that they have a strong and experienced team.
- Participates in hand over meeting from feasibility team member.
- Coordinates site identification tasks; including but not limited to Site Feasibility Questionnaires (SFQs).
- Coordinates confidentiality agreement (CDA) negotiation and execution.
- Compiles site set-up process and develops site activation timeline for each site.
- Works with the study team to determine the IP Document Package requirements.
- Completes templated documents with study specific information.
- Develops IP Documents Release Package cover letter and gain approval as required.
- Coordinates and distributes the Essential Document Package (EDP) to the clinical sites.
- Reviews essential and non-essential documents from sites to ensure all required documents are accurate and complete.
- Develop Country/Site submission packages, per country requirements.
- Perform Competent Authority and Ethics submissions per country/site regulatory processes.
- Develop Submission Package to perform supplementary submissions, if applicable per country regulations.
- Coordinates the development of the site contract and budget templates.
- Develop Ancillary Budget and Contract templates, when needed (e.g. Laboratory, Pharmacy, Radiology) and perform facility negotiations and track the progress.
- Completes site contract and budget negotiations.
- Support with Import License and Export License applications, if applicable, per protocol and country requirements.
- Track the progress of site ID, Submissions, and Site Contracts negotiations activities in a Start-Up Reporting tracker/tool
- May support with country label reviews per regulations and country requirements
- Interfaces with Sponsor representatives and internal project team
- Compiles project-related activation packages (e.g. IP release, regulatory submission)
- Responsible for ensuring the filing and quality control of Site ID and activation documents during the startup period in the Trial Master File
- Confirms with Project Manager (or designee) that all study supplies, tools, etc. are available to ship to site in time for Site Initiation Visit (SIV).
- Inputs study timelines and other required fields into the tracking system, monitors and updates fields as study timelines or other information changes.
- Escalate study issues appropriately and in a timely manner.
- Assists with the development and maintenance of clinical study plans.
- Responsible for understanding the CSS budget on each project and the actions required to maintain it.
- Coordinates site ID and activation related meetings including agendas, decision logs and action item tracking.
- Collaborates and supports the project team with amendments to the protocol, ICF, site contract and site budget as needed.
- Assists with department activities and initiatives, as appropriate (e.g., process improvement, clinical system subject matter expert).
Education: University degree or equivalent education in a related field of study.
Experience: At least 4 years in pharmaceutical research field (CRO, pharma, site, etc.) and 3 years of applicable industry experience as part of start-up team or CRA role with start-up experience.
- Must have demonstrated expertise in relevant clinical and/or business operations activities; including but not limited to site regulatory document collection/review, ICF development/negotiation and/or site contract/budget negotiation.
- Strong ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.
- Strong working knowledge of ICH/GCP guidelines and local country ethics and competent authority regulations (requisite knowledge may be obtained during performance of job duties through appropriate training (both on site and/or e-training programs).
- Exceptional written and verbal communication skills.
- Strong ability to work well under pressure and coordinate multiple tasks that affect critical timelines.
- Strong ability to multitask and work in a fast-paced dynamic environment required.
Reporting to the Finance Business Partner, the Purchase Ledger Clerk is responsible for providing finance administrative support, undertaking basic accounting tasks.
The person in this position will work directly with the Corporate Finance Team to help maintain the accounts and deal with basic financial transactions on behalf of the business.
- Purchase ledger processing.
- Credit card transactional processing.
- Support the corporate finance team as required.
Education and Experience
- Preferably AAT Qualified, though part qualified/studying towards AAT or qualified by experience will also be considered.
- Minimum of 2 years' bookkeeping experience
- Ability to manage time and activities
- Excellent interpersonal skills with a can do attitude
- Good organisational skills with a proven ability to meet deadlines
- Good eye for detail
- Proactive and self-motivated
- Interest in working in a high growth company
- Commitment to excellence and high standards
- Good working knowledge of Microsoft office, including outlook and excel
- Preferably experience of working with Xero and/or Netsuite
- Experience of working in a pharma/construction/professional services industry would be an advantage
Please note: Temp to Perm role with an initial 9 month fixed term contract, part time – 25-30 hours a week, flexible working pattern available.
The Clinical Project Manager is responsible for planning and implementing the team objectives for clinical trials and delivering to time and budget. He/she will plan and manage the clinical trials in order to ensure the safe, effective and efficient delivery of all operational aspects of studies through all phases of study management in accordance with appropriate quality standards. He/she is accountable for the development, project management and delivery of site management plans and will work closely with clients and colleagues within the business in order to understand the requirements and deliver against these successfully.
Reporting to the Associate Director of Clinical Operations, the person in this position will work closely with the Client Key Account Manager and the Contracts and Proposals Manager in order to deliver the required services to clients.
- Develop the initial scope of work for clinical projects, working with the client and the Aptus Clinical team to clearly define the requirements, project costs/budget and resources
- Develop a quality management plan and associated risk log for all projects
- Lead the resourcing of study teams and the study site set up, contributing to the study feasibility, site selection, resource plan and driving the first subject in, ongoing recruitment, risk management and study delivery plan
- Lead the site management activities including the development and management of regulatory documentation, scheduling and management of all site visits in line with the agreed client contract requirements
- Proactively interface with the Aptus Clinical team and the client in order to manage the project and develop solutions to issues and challenges which arise
- Provide clinical operational expertise for the local study team and ensure compliance at all times with company governance guidelines
- Coordinate the daily operations of the Aptus Clinical team, including definition of the project timelines with the assigned study team, coordination of the remote review of clinical data, review and approval of trip reports and follow up, management of project meetings and ensuring the provision of required training for the CRAs
- Manage the delivery of study milestones and patient recruitment targets by the team proactively addressing deficiencies/deviations
- Manage all project resources, including conducting regular reviews of budgets, ongoing monitoring of costs and potential overruns and the implementation of proposals for cost-effective solutions/mitigation strategies as required
- Ensure any potential out of scope activities are tracked and discussed with the Contracts and Proposal Manager on a monthly basis
- Work with the Associate Director for Clinical Operations to define and manage the performance of the CRA’s and CTA’s as required, providing coaching and supporting the development of clear expectations and goals to ensure team performance overall is fully optimised
- Ensure all project documentation is managed appropriately and prepare for audit responses as required. Prepare weekly/monthly report information for the clients
- Develop and maintain strong, positive relationships with clients and key internal stakeholders to clearly understand the business processes and the short and long term business objectives
- Support CRAs in site data collection and locking, query resolution, progress to data base lock
- Support CRAs or if necessary personally undertake study start up activities by obtaining documents for drug release and ensuring site documentation is correct
- Participate in the analysis, summary and reporting of clinical data for regulatory or market purposes as required
- Collaborate in the preparation of quality/compliance reviews, internal audits and regulatory inspections and ensure adequate and timely CAPA follow up
- Identify areas of best practice and contribute to activities to improve and maintain the quality and effectiveness of processes and activities across the teams
- Maintain knowledge of all relevant clinical processes and SOPs to ensure appropriate compliance to ICH-GCP and ABPI code of practice
- Organise, conduct and report local quality control activities with CRAs (e.g. accompanied visits, review of monitoring visit reports, review of monitoring quality, review of SMF and ISF documents and key system checks)
- Manage and control allocated budget spend for the areas of responsibilities within this role
- Develop, implement and maintain company policies for which you are the named Subject Matter Expert
- Contribute to proposal generation and participation in bid defence meetings
Education and Experience
- Degree or equivalent qualification
- Advanced knowledge of good clinical practice and understanding of local Competent Authority regulations is required; international clinical trial experience and knowledge of other country requirements is preferred
- A minimum of 10 years’ clinical study management experience in biopharmaceutical industry including a minimum of 5 years in oncology and 2 years as a clinical study lead/project manager is required; global clinical trial experience is highly preferred
- Proven ability to influence and manage both clients and investigators.
- Ability to lead and influence in a fast paced and collaborative environment
- Excellent interpersonal, negotiation and conflict resolution skills
- Proven ability to lead projects and motivate at all levels
- Ability to manage and develop others
- Ability to work within and lead teams
- Ability to contract with others
- Ability to build teams and bring stakeholders together
- Ability to lead and facilitate groups and workshops
- Can operate on the big picture as well as with detail
- Excellent presentation skills, with solid oral and written communication capabilities
- Strong technical skills using PowerPoint, Excel and Word
The Senior Clinical Trials Administrator reports to the Associate Director of Clinical Operations and is responsible for providing the administrative support to the clinical development/project teams and maintaining a range of clinical documentation. He/she will be focused on supporting external client teams on behalf of Aptus Clinical, as well as our internal Clinical Services team.
The person in this position will work closely with project teams to ensure that Clinical Trial Administration is performed in line with ICH-GCP allowing successful delivery of trials whilst protecting subjects’ rights, safety and wellbeing and the production of reliable clinical trial data.
- Support the clinical trial activities on behalf of Aptus Clinical with regard to time, cost and quality and in accordance with SOPs, ICH-GCP guidelines and relevant regulations
- Set up and maintain the documentation folders associated with product development and the Trial Master File (TMF) in compliance with ICH-GCP
- Ensure the TMF index is kept up to date
- Coordinate the collection of essential documents during site set-up
- Assist in the development of processes and procedures in order to ensure that robust forecasting and scheduling of trials occurs
- Assist the project managers in the production of study reports and updates as required
- Set up trial specific meetings, taking minutes and tracking screening and enrolment across clinical sites
- Track and process investigator site payments
- Manage the clinical trial supplies for a study, including the tracking and shipment of materials e.g. lab kits
- Assists the project team with preparation and shipment of Clinical Trial documentation including: Investigator Site File, Pharmacy File, Investigator Brochure, Protocol and study manuals.
- Update and maintain trial tracking systems in accordance to the demands of the study e.g. investigational product tracking, payment tracking, monitoring visit tracking etc.
- Serve as an office-based point of contact for all sites during the trial
- Develop and maintain good working relationships with Investigators and study staff
- Assist with corporate administration activities according to need and availability
Education and Experience
- Degree or equivalent qualification in life sciences or nursing
- Sound knowledge of the clinical trial processes and procedures including regulatory standards
- Proven track record in working within clinical research in the pharmaceutical, CRO or NHS environment
- A good understanding of ICH-GCP and regulatory requirements
- Experience in maintaining Trial Master Files/Investigator Site Files in compliance with ICH-GCP (ideally experience in using the DIA reference model).
- Ability to work collaboratively with others, influencing and managing conflict
- Willingness and ability to travel domestically (and occasionally internationally) as required
- Excellent verbal and written communication and interpersonal skills
- Strong organisational and time management skills with an ability to multi task and work independently
- Strong technical skills using PowerPoint, Excel and Word