Syneos Health needs candidates with prior experience independently managing trial committees, adjudication and clinical trial documentation. Candidates should be able to mentor staff and communicate clearly with internal teams and customers.
Candidates need a medical doctorate, board certification in ophthalmology, and clinical research experience in the therapeutic area. They must know FDA and global drug development regulations and be fluent in written and spoken English.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, email, voicemail
3+ YOESyneos Health needs candidates with 3 to 5 years of medical writing experience, including protocol writing, and experience in biopharmaceutical, device or CRO settings. Strong knowledge of FDA and ICH regulations, excellent English and AMA style, and experience with Veeva/CARA are needed.
5+ YOESyneos Health needs candidates with a bachelor's degree, at least 5 years of medical writing experience in biopharma or CRO settings, and strong regulatory knowledge. Proficiency in MS Word and electronic document management systems is required.
MS Word, electronic document management system, document templates
5+ YOECandidates need at least 5 years of lead regulatory writing experience, including Phase 2 and 3 studies and documents such as CSRs, IBs, patient narratives and integrated summaries. Strong project management, client-facing and time management skills are required.
Candidates need a graduate degree in biostatistics or a related field, extensive clinical trial experience, and strong knowledge of biomarker evaluation, especially in oncology and ctDNA. Proficiency in statistical programming and excellent English communication are required.
Candidates need strong knowledge of FDA, EU and industry guidelines, plus expertise in AMA Manual of Style and medical copy editing. Leadership, mentoring and project management experience is expected.
Editing, Technical support, Editorial standards, Scheduling, Process improvement
Candidates need solid medical writing experience and a strong grasp of regulatory guidelines such as ICH E3 and company standards. They must manage projects on time and on budget, and build working relationships with clients and cross-functional peers.
Presentation skills, Documentation, Data management, Regulatory affairs, Technical support, Leadership
Candidates need a bachelor's degree or RN, proven site management and monitoring expertise, and knowledge of GCP and ICH guidelines. Strong communication, conflict resolution and problem-solving skills and good computer skills are also needed.
Candidates need a graduate degree in epidemiology, statistics or public health (doctorate preferred), in-depth study design experience, and basic statistical programming skills in SAS, R or Python. Strong written and spoken communication and leadership skills are also required.
Candidates need a graduate degree in epidemiology, statistics or public health, with a master's required and a doctorate preferred. They should have in-depth experience with many study designs, basic statistical programming skills, strong written and spoken communication, and proven leadership.
Candidates need a master's degree in epidemiology, statistics or public health (a doctorate is preferred), deep experience with varied study designs, and basic statistical programming skills in SAS, R or Python. Strong written and spoken communication and proven leadership are also required.
Candidates need an undergraduate or master's degree, ideally in a scientific or statistical field, and extensive SAS, R or Python programming experience in a real world data setting. They also need SQL, claims data experience, ICD coding knowledge and strong English communication skills.
Candidates need a bachelor's degree or RN in a related field, or equivalent experience. They need knowledge of GCP/ICH guidelines, good computer skills, strong communication skills and the ability to travel up to 75%.
Electronic data capture systems, Trial Master File, Clinical data tracking systems
Candidates need a bachelor's degree or RN in a related field, proven leadership of teams and project milestones, and expertise in site management and monitoring. They also need knowledge of GCP/ICH guidelines, budget management, conflict resolution and good computer skills, and preferably experience with risk-based monitoring.
Candidates need fluency in both French and English, plus clinical monitoring experience and a working knowledge of ICH-GCP, relevant regulations and company SOPs. Strong judgment, adaptability to changing priorities and comfort with electronic data capture systems are expected.
Electronic data capture systems, Tracking systems, Case report forms
Syneos Health needs candidates with a bachelor's degree or RN in a related field, demonstrated site management and monitoring expertise, and knowledge of GCP and ICH guidelines. Strong leadership, conflict resolution, budget and computer skills are also required.
5+ YOECandidates need a master's or PhD in biostatistics, statistics, epidemiology or a related field, plus 5+ years of real-world data analytics. They need SAS, R or Python, SQL and OMOP knowledge, and experience with observational study design and causal inference.
Candidates need a bachelor's degree or RN in a related field, knowledge of Good Clinical Practice and ICH guidelines, good computer skills, and strong communication skills. Travel of up to 75% on a regular basis is required.