TFS HealthScience is excited to be expanding our SRS Project Management team and we are looking for an experienced, highly motivated Senior Project Manager who shares our vision of providing clinical research excellence. Our Project Management team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.
Together we make a difference.
The Senior Project Manager has the overall responsibility for managing projects in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations. The Project Manager will plan and pro-actively manage multidisciplinary study teams (including Site Management, Data Management, Statistics, Medical Writing, Regulatory and Safety) to ensure key milestones are achieved and studies are performed within budget, on schedule and in compliance with the appropriate - and quality standards. In larger studies the Project Manager could be responsible for managing parts of the project, e.g. Site Management.
- Active participation in the preparation of Clinical Development plans
- Collaboration in the elaboration and review of clinical trials outlines, DSUR, IB, and international (Europe/FDA) submission dossiers.
- Participation and reporting to the Project Team (PT), Medical SubTeam (MST), Core Teams and, any other team as needed.
- Participation in advisors, partners or in- and out-licences meetings, including the preparation and review of associated documentation.
- Collaborate in the creation of presentations for congresses and/or papers for medical journals based on CT results.
- Planning and conduct of clinical trials/experimental and cosmetic testing/investigations with medical devices, including preparation, review or approval of all associated documentation (synopsis, protocol, report, timelines, all study plans –statistical, data management, monitoring,…-, technical specifications, IMP related documents, and any other study-related documentation) and management of study budget, including approval of invoices payment and forecast planning.
- CRO and other vendors selection for the outsourcing of Clinical Trials and other activities task according to Project needs.
- Leadership and coordination of the different areas and activities of the “Clinical Study Team”(CST), and organisation of periodic meetings.
- Cooperation with other department representatives when needed
- Participate in the preparation of any documentation related to competent national and local authorities, and the relevant ethics committees, coordinate and boost regulatory submissions and answer to their questions.
- Organize and/or participate in the Investigators Meeting/Pre-initiation visits/Kick-off Meetings presenting the protocol and study operational aspects (study drug, monitoring) of the study, and visit research sites ad-hoc
- Supervise and boost sites activation and recruitment progress, database cleaning, and timely SAE reporting.
- Review of the Trial Master File key documents related to activities under CTM direct responsibility
- Collaboration in the planning and conduction of audits and CAPA implementation, and in the inspections to the participating sites or sponsor.
- Ongoing review of CT blinded data (e.g. for identification of protocol deviations, ensuring accuracy of data cleaning, early detection of unexpected trends on patients baseline characteristics).
- Leadership of the “Blind Data Review Meeting”.
- Ensuring the CT are conducted in accordance with Good Clinical Practices (GCPs) , with applicable international quality standards, with the agreed (CRO) SOPs, policies and standards, as well as any other guidelines given by the Head of Global Clinical Operations (GCO) and GCL.
- Report and discuss with the Medical subteam Escalation to the GCL and/or Project Manager and Head of GCO any significant deviation (or a risk for deviation).
- Continuing education and training on medical and clinical research topics. Assistance to courses, congresses, trainings, investigator’s meetings, specialised journals reading, international conferences, etc.
- Collaboration in SOPs update/creation/training.
- Graduate in Health Sciences (Pharmacy, Biology, Biochemistry and/or Medicine and Surgery).
- Participation in Clinical Trials
- Pharmaceutical Industry business
- Project Management
- Basic Statistics and/or Biometry
- Basic Pharmacokinetics, Clinical Toxicology and Pharmacology
- Others: Preferably Doctor’s degree
- English essential
- Other languages desirable
- Communication and Negotiation skills
- Previous Experience in the role
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