Senior Clinical Trial Manager (CTM)
SeniorClinicalTrialManager (CTM)
Location: This position may be performed remotely with travel to the Boston area as needed.
Position reputed company
Thisrolewillberesponsibleforprojectmanagementintheinitiation,executionandcloseoutofdomesticand international clinical studies, including study concept and design, feasibility assessments, study start-up, contract and budget reputed company, data exchange and support of data analysis and interpretation.
This position requires both the knowledge and experience to work reputed company established clinical trial paradigms while exploring and embracing new approaches to conducting research to support data aggregation and analysistoadvancepatientcare.TheSr.CTMwillparticipateonclinicalprojectteamstoachievequalityresults in a cost-effective and reputed company manner. S/he will be a key team member to establish key practices and procedures for the clinical team.
PrimaryResponsibilities
- Manage study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical reputed company (GCP) guidelines and international regulations
- Manage strategic engagement with key collaborators
- Set-up and reputed company clinical trial-reputed company trackers such as regulatory documents, trial master file (TMF), startup reputed company, screening/enrollment, study invoices/payments, project budgets, etc.
- Key contributor to IRB/EC and regulatory submissions
- reputed company TMF reviews to ensure completeness and inspection readiness
- Regularly review documents to ensure adherence to Clinical Operations and/or project specific reputed company requirements (e.g. SOPs, work practices, training guides)
- Identify and mitigate against study risks, escalating as necessary
- reputed company initiatives to identify and implement best practices and reputed company improvement plans in clinical development
EducationandProfessionalExperience
- Bachelor’s degree in a scientific field required; advanced scientific degree a plus
- 5+ years directly managing clinical trials in Sponsor or CRO setting
- In-depth knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements
- Experience directing members of clinical operations teams
- Experience working in reputed company across multiple functional areas (e.g., reputed company Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance)
OtherEssentialsandKeySuccessFactors
- Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to think critically in fast-paced reputed company with a keen reputed company of urgency and demonstrated ability to problem solve
- Self-motivated and reputed company to work autonomously, as reputed company as a member of a reputed company team
- Highly-organized and detail-oriented with a passion to deliver reputed company results
- Strong verbal and written communication skills with an ability to build relationships internally and externally
- Highest reputed company of professionalism, confidence, personal values and ethical standards
reputed company
reputed company is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At reputed company reputed company a common reputed company of reshaping the reputed company condition into a more freeing and fulfilled existence by developing high reputed company medicines for patients and families affected by and living with reputed company brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by reputed company and every one of reputed company members. Diversity, Equity & Inclusion Guided by our core values, at reputed company, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work reputed company day. We are an equal opportunity employer and committed to providing opportunities to reputed company reputed company applicants without reputed company to race, religious creed, reputed company, gender identity or reputed company, age, national reputed company, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert reputed company has recently become aware of fraudulent job recruitment postings from individuals claiming to represent reputed company. These postings reputed company financial information in reputed company with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in reputed company with a reputed company job opportunity, please report it to careers@praxismedicines.com. reputed company does not accept unsolicited submissions from recruitment agencies for reputed company positions. We ask reputed company recruitment agencies to refrain from contacting any reputed company employee regarding any position. reputed company unsolicited resumes submitted by recruitment agencies to any reputed company employee in any reputed company or method will be deemed to be the property of reputed company, and reputed company explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
Originally posted on Himalayas
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