Work with us
Looking to express your talent in a flexible environment while making a real difference to drug development?
Changing the status quo and setting new standards takes extreme ownership, freedom to contribute and a high dose of collaboration.
Our approach to work:
- Productivity comes from people's ability to use their time wisely and from active collaboration, not from inflexible working requirements.
- People deserve to have adequate time to enjoy their families and hobbies, without wasting time on non-value adding things like traffic jams.
- Talent is not restricted by geography - technology helps shortening distances.
- Sustained talent retention is achievable through flexible working models that truly support work-life balance.
Before applying for an opportunity with CLINERGY...
...you need to understand we are not your typical employer:
- We don't value job titles that much. We believe making sure you have the right opportunities to grow and develop new skills is more important than that.
- We are not interested in seeying you in the office very often (even though we always love to :-)). We are interested in making sure you have quality time with your family and friends and find a schedule that provides you with the opportunity to be at your best - together we agree on how many hours (and what hours) work best for you.
- We do not foster internal competition - very often our own pre-conceptions are our biggest opponents and that is where our focus should go to.
What we offer
What we don't offer
Flexibility – work-life balance looks different to every person. We offer truly flexible working hours working from wherever suits you best, according to your needs.
“Free snacks” – we won’t offer you perks that may be of little interest just to be able to say we offer a huge range of benefits (that people can’t even use as they have no free time to do so).
Competitive compensation – our model enables us to offer very competitive compensation regardless of whether you take on a single project or work with us on a continued basis.
Red tape – we won’t offer you a bureaucratic working environment where politics wins over great ideas and hierarchy wins over freedom to make things happen.
Skills development – our strong focus on skills development allows you to reach superior professional standards throughout your professional journey with CLINERGY.
Biased assessments – we won’t offer performance evaluation systems based on subjective criteria and whose outcomes are limited by any caps established a priori.
We appreciate our approach to work, productivity and work-life balance may not suit everyone, but if those elements resonate with you please submit your updated CV through the CV upload box at the end of this page and we will keep your details on our database for future opportunities.
Current Openings:
Are you an accomplished CRA looking for an opportunity to work independently from home having the freedom to choose the best way to deliver your goals, how many work hours (and what hours) best fit your lifestyle to achieve a real balance while doing what you love? At CLINERGY we are not looking for employees, we seek partners that are passionate about advancing science.
We are looking for highly skilled CRAs to join its growing team and to work on exciting clinical projects to make a real impact on drug development and public health.
Responsibilities:
- Support and conduct site feasibility and selection activities;
- Support and conduct preparation activities for Site Initiation Visits;
- Conduct independent monitoring to verify accuracy of study data vs. source records;
- Ensure requirements for patient privacy are met;
- Generate and collect study documentation such as consent forms, Essential Documents, Case Report Forms and Investigator Agreements;
- Conduct and tracks progress of sites to initiation, enrolment and screening, interim monitoring and close out requirements;
- Ensure no study tasks are conducted prior to IRB/EC approval and formal site activation;
- Liaise with sites on study budgets and contracts with sites;
- Review Serious Adverse Event (SAE) narratives with sites and medical monitor; Ensure adverse event reporting is done in accordance with regulatory requirements;
- Maintain documentation in electronic and paper Trial Master Files;
- Maintain close communication with study sites, investigators, and vendors;
- Organize, conduct and report on Site Qualification, Site Initiation, Interim Monitoring, and Close-out visits;
- Verify the accuracy of study results;
- Identify and resolve site issues;
- Manage all aspects of relationship and operational activities for designated clinical investigational sites;
- Participate in other duties and activities as assigned
Requirements
- Bachelor’s degree in life sciences (Mandatory);
- 3+ years experience as a CRA (Mandatory);
- Advanced/Fluent in English (Mandatory);
- Experience in cardiology and infectious diseases/vaccines trials is a plus;
- Strong medical and clinical knowledge of indications, therapies, and patient population
- Proven track record of having good sponsor, investigator, site, and vendor relations
- Strong computer skills including EDC system experience
- Demonstrated detailed knowledge of guidelines, systems for clinical trial management and of ICH GCP and international regulations and practices
- Travel from 50-75% of the time may be required
Skills
- Excellent interpersonal, verbal, and written communication skills
- Attention to detail and strong organizational skills
- Good problem solving skills
- Enthusiastic and energetic
Note: Candidates who do not possess the mandatory requirements speficied above will not be considered.
If you think this opportunity may be a good match, please send your updated CV to info@clinergyhealth.com. By providing your CV you express your consent for the processing of your data in accordance with our personal data privacy note (available below for reading).
Personal Data Privacy Consent
By providing your CV you provide your consent for personal data processing in accordance with our Privacy Notice.
Are you an experienced Clinical Study Manager looking to make a difference on people’s lives by helping advance science while working on a flexible model that truly brings the term “work-life balance” to life? Then this might be a good opportunity for you.
The role will be focused on study management, ensuring high data integrity standards and compliance with applicable guidelines and regulations for clinical trials on different areas. You will have freedom to lead all aspects of the study, ensuring its successful conduct and completion.
Responsibilities
- Develop and manage multidisciplinary project team members related to project management activities requiring interaction with different groups including clinical science, data management, pharmacovigilance, shipping/logistics, regulatory affairs, quality assurance and business development during clinical study lifecycle.
- Define and monitor project scope, timelines and deliverables from project initiation to close out. Ensure project plan aligns with contract requirements, and address any reconciliation required.
- Schedule, plan for, and document regularly scheduled project team meetings. Assess project issues, propose resolutions to the project team, Clinical Ops lead and/or the Sponsor, and then track implementation of resolution through to completion.
- Ensure the overall quality of project services and deliverables by documenting project/clinical trial progress to ensure completeness of documentation and data collection, management of supplies and resources in adherence with the project timelines, budgets and quality standards including central laboratory and contract/academic research organisations.
- Participate in the design, writing and review of all project-related documents including: budgets and proposals, change orders, and study content documents including protocols, case report forms, statistical analysis plans, study reports and monitoring documents. Development of informed consent forms, study documents and study management tools.
- Manage project tracking and performance efforts:
- Implement risk mitigation actions at the project level (raise to program level, as necessary)
- Implement corrective actions as needed to maintain project performance
- Ensure quality reviews occur at key points with the participation of the appropriate personnel
- Ensure project deliverables comply with corporate standards and quality guidelines
- Monitor the project plans on a weekly basis for changes to the critical path and milestones, and for other issues and ensure the change control process is followed.
- Conduct regular status meetings with the project team, reviewing project schedule, risks, issues and outstanding action items. Disseminate appropriate project information to all team members and Clinical Ops lead on a regular basis.
- Contribute to the Lessons Learned Report, with inputs from team members, at the completion of major project milestones.
- Regularly review project contract terms and conditions, as well as baselined and approved project plan to ensure that all assumptions are still valid.
- Summarise monthly status reports of Project team and provide consolidated monthly status updates of current assignments to the Clinical Ops lead.
- Assist in IRB issues.
- Prepare site agreements, contracts, and financial/site payment tracking during study conduct.
- Provide necessary updates and reports to the Sponsor as outlined by the contract.
- Provide all job-related progress reports/technical reports as requested.
- Ensures compliance with all applicable corporate and client policies and standards.
- Provide project related fiscal oversight.
- Provide line management for Project Specialists and other staff as assigned.
Requirements
- BA/BS degree in a scientific/business field, with sufficient work experience in clinical research.
- 7+ years of experience in clinical research, or at least 5 years of experience in clinical research when combined with 2 years or more of project management experience.
- Ability and willingness to travel up to 25%
- Must show demonstrated skills in Project Management, Leadership, Risk Management, and Decision Making. Qualification in a Project Management or equivalent (PMI certification is a plus.)
- Possess the ability to organize, instruct and supervise staff, while promoting group effort and achievement.
- Ability to identify issues, track progress, and follow through on actions to meet customer satisfaction.
- Skilled in communicating issues, impacts, and corrective actions to varying levels of corporate personnel and customer leadership personnel.
- Excellent written, verbal, and interpersonal communication skills, organisational skills and a great attention to detail are required. Must be able to work as a member of a team and possess good problem-solving skills
- Possesses thorough knowledge of the Good Clinical Practice (GCP) guidelines ICH regulations for conducting clinical drug trials
Soft Skills
- Strong people management skills
- Excellent communication skills
- Assertiveness and ability to build impactful relationships
- Excellent organisational and planning skills, analytical mind
- Team player, strong sense of urgency, performance driven and delivers to timelines
- Business understanding
If you think this would be an interesting opportunity for you, please send your CV to info@clinergyhealth.com