Clinical Project/Trial Manager, Synklino / 1787
Synklino is an ambitious privately held Biotech company located in Charlottenlund, Copenhagen (by September 1st 2022 a planned new location at Kultorvet, Copenhagen). Synklino was founded in 2017, and has a drug candidate; SYN002, for treatment of CMV in transplantation patients, which is in development, as well as a technology platform for targeting chronic virus infections. See more at https://www.synklino.com/
Synklino is developing their first drug candidate, SYN002, for treatment of CMV infection in transplant recipients. To help them, you will have a unique opportunity to be part of an entrepreneurial culture working together with talented and competent senior colleagues, in their endeavors to improve lives of transplant patients through science. On behalf of Synklino, Best Talent is now looking for an experienced and motivated candidate to reach their goals.
Clinical Project/Trial Manager
- Ambitious, strong & valuable anti-viral Biotech company
- Oversight and Management of Clinical Trials
- A challenging job with great influence and part of a growth adventure
Are you an operational superstar? Would you like to have a unique opportunity to take part in building a strong and valuable anti-viral Biotech company heading for an IPO?
Synklino recently initiated development of their first drug candidate, and the project is planned to enter into clinical trials in the first half of 2023. In this position you will drive, and manage clinical phase 1 and early phase 2 trials. The trials will be conducted in multiple countries including Canada and EU.
While the team enjoys working together in the Synkliono head quarters, Synklino is a virtual company with all research and development activities outsourced. As Clinical Trial Manager you are a natural key player when joining the SYN002 project. You are a genuine team-player and will collaborate closely with multiple disciplines at Synklino. As clinical trial (project) manager you are at the heart of research. You keep studies running on schedule, help manage budgets, choose and liaise between vendors, report on results, enforce compliance, and fulfill other key duties. In this role, you will work closely with all the internal and external project partners, vendors and CROs. Here you handle all contracts, budgets, clinical trial related documentation, goals and milestones and ensure study related deliverables will have the right quality of data will be delivered at the right time.
Synklino offers a challenging and versatile job in an innovative, fast paced, flexible, well-organized, and committed Biotech environment with a high degree of influence and opportunity for personal and professional development. You will report to the chief medical officer in Synklino.
- Monitor and report on the progress of clinical trials, which includes budgets and timelines
- Prepare, oversee, and review documents that are related to assigned clinical study
- Arrange or help in organizing clinical study meetings
- Ensure the availability of necessary resources for the execution of clinical projects
- Review and approve invoices being presented by study vendors and external consultants
- Answerable to questions and issues brought up by vendors and external consultants
- Help in the training and development of clinical staff
- Lead the clinical project team and various study team meetings
- Oversee the pattern and manner in which clinical research study is being conducted
- Fully involved in resolving issues; take part in procedure improvement initiatives
- Attain clinical study’s goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process
- Work hand-in-hand with clinical trial managers and document control personnel to manage documents that are related to the clinical study.
You have a relevant degree and experience in management of clinical trials and clinical CRO selection and oversight. You have more than 5 years of experience in a similar position and are an excellent project manager and you execute day-to-day project management at a higher level.
You are able to work effectively with other disciplines such as discovery and research, manufacturing, DMPK, translational medicine and QA and have experience with developing study related clinical and regulatory documents, submissions and obtaining the necessary approvals.
You have the following abilities, skills and knowledge
- Excellent communication skills so as to be able to effectively convey messages across to both study team members and other external persons like vendors and external consultants
- Good problem-solving, organizational, and leadership skills are highly required
- Ability to work with little or no supervision
- Ability to pay keen attention to detail at all times
- Able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects
- Able to work as part of a team and lead a team
- Have a ‘one of a kind’ work ethic, and must exhibit a great level of self-discipline
- Ability to organize and motivate other members of the study team
- A Bachelor’s and/or a Master’s degree in any science or health related field
- A minimum of 5 years experience in the field of clinical research of which 2 years must have been in a project lead role
- Proficient user of basic computer applications for the execution of daily project operations
- Experience in writing clinical study procedures and other clinical document.
As a person you are a self-driven, creative, structured, and an accountable team player with humor. You are positive, committed, and full of drive. It is important that you are focused, can prioritize, and keep calm when deadlines are tight. You are good at solving problems and thrive with a well-balanced workload and with a good work life balance. You are fluent in Danish and English, both written and spoken. In other words, you have the desire to support and enrich Synklino’ s culture and would love to work in a Biotech company.
Best Talent is responsible for the recruitment process at Synklino and reviews your application on a confidential basis. Forward your application including your CV in English marked”1787/CTM” by e-mail to firstname.lastname@example.org. You can read more about Best Talent on www.besttalent.dk.