Provide oversight for and participate in audits of; clinical safety and PV vendors, PV partners, electronic clinical and PV data systems, clinical and post marketing PV documents. The Director of CQA-PV is the supervisor of the Clinical Quality Assurance Department with responsibilities for quality ...
Investigator Brochures, and clinical study reports; review SAPs and TLF shells; participate in emerging clinical trial data evaluation and interpretation; ensure that assigned studies are conducted according to GCPs and Fusion’s SOPs; conduct literature searches and reviews, meta-analyses, and publi...
Proven ability to lead business/IT teams responsible for implementing, enhancing, and supporting Clinical Development software tools/technology including Veeva Vault Clinical Suite, SAS, elluminate and Clinical Data Management Systems (CDR). IT solutions owner to support BlueRock's rapidly expanding...
Reporting into the VP, Clinical Operations, the Director, Clinical Operations is accountable for the operational strategic planning, oversight and successful delivery for one or more clinical trials/programs. Function as Clinical Operations lead for clinical development program(s) ensuring successfu...
Senior Director, Clinical Pharmacology. Reporting to the SVP of Research, the Senior Director, Clinical Pharmacology will drive all aspects of the translational strategy, including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and biodistributio...
Responsible for the clinical content of clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports. Senior Medical Director, Clinical Development. You will join a smal...
Moderna is seeking an Associate Director in the Biomarker Operations group within the Clinical Biomarkers Department to provide leadership and strategy to impact biomarker operations deliverables in collaboration with biomarker leads, clinical teams, and partner CROs. This position will lead collabo...
Direct and oversee clinical studies at multiple phases of clinical development, including clinical strategy, study design, protocol writing, Institutional Review Board (IRB) applications, site training, medical monitoring, documentation and data analysis. Reporting into the SVP, Global Clinical Deve...
The Associate Medical Director (AMD), under the direction of the Director of the Office of Clinical Affairs (OCA) or his/her designee, is responsible for providing clinical expertise to OCA and EOHHS program staff. Provide clinical leadership and mentoring for the OCA and MassHealth staff and work c...
The Associate Director of Clinical Data Management supports the Senior Director of Clinical Data Management in running the department efficiently, to appropriate quality standards and in line with company strategy. The Associate Director of Clinical Data Management is an effective input into strateg...
The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a high priority immunology program. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across...
Seeking an experienced Physician Assistant to serve as Director of Clinical Operations for an Urgent Care Center. Clinical and administrative position. Acts as a liaison and facilitator between the urgent care center and the hospitals in addition to clinical duties. Disseminates all clinical protoco...
Under general direction, the Clinical Director partners with a designated Service Line Chair and Executive Director(s) - Service Line to assure the execution of Atrius Health’s strategy and goals at an organization-wide specialty level. May provide nursing leadership and clinical management of a ser...
The Director, Clinical Quality within Research & Clinical Development Quality Assurance will be responsible for the oversight and support of the Sarepta Clinical Development and Real World Evidence portfolio. This position will be a core member of the Clinical Trial team and provide Clinical Trial t...
DIRECTOR OF CLINICAL SPORTS PSYCHOLOGY & ATHLETE WELLNESS,, Student Health Services. The director performs a wide range of complex tasks including coordinating the clinical treatment team of mental health providers which delivers group, individual and athletic team services for all BU student-athlet...
Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT. The Associate Director, Clinical Data Management is responsible f...
Leads clinical teams as Global Clinical Lead or represents Clinical Science on Project and Clinical teams. Serves as an advisor or supervisor to other medical directors or clinical scientists involved in these activities, and be accountable for the successful design and interpretation of clinical st...
Reporting to the Head of Drug Safety, the Associate Director, Clinical Safety Operations Scientist will lead and oversee all safety operations activities including vendor management, audits, SOPs, trainings. The Associate Director will provide all training to the vendors, clinical sites and int...
Director Clinical Operations Boston. We are working on behalf of our client to find a Director of Clinical Operations based in Boston. Oversee clinical trial timelines risks and challenges ensuring accurate and timely delivery. Lead crossfunctional collaboration to support clinical trial objectives....
The CL will apply deep medical and clinical knowledge to translate clinical research ideas into high-quality decision-making data, working closely with subject matter experts from statistics, clinical pharmacology, and other team members. The Clinical Lead (CL), Internal Medicine RU (IMRU) will be t...
Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical phar...
Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. The Ass...
REQUIRED: doctorate in clinical or counseling psychology from an American Psychological Association (APA)-approved doctoral program; completion of APA-approved clinical internship or its equivalent; Massachusetts licensure or license eligible; at least five years of supervised clinical internship/fe...
Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. The Ass...
Reporting to the Global Project Head, the CRD leads clinical trial strategy and execution of assigned program(s) within the clinical development team, including interactions with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Phar...