- Collaborate on and review the scientific content of clinical documents such as protocols, informed consent documents, CSRs, and investigator brochures according to agreed-upon project timelines.
- Provide protocol oversight and input into informed consent documents
- Support the monitoring of patient safety during clinical study and participate in the global product safety reviews including the appropriate tracking and follow-up of adverse events.
- Review and collaborate with Development Medical Director on the approval of risk profiles to ensure appropriate communication to risk to study subjects.
- Participate in data analysis, data review, development of scientific data dissemination, and preparation of final reports and publications.
- Support data analysis and the development of slide sets and publications
- Other activities related to Clinical Research/Trial Execution and Support
- Advanced Health Degree (MD or DO) required.
- Completed residency and board certified in respective medical area
- Ph.D, PharmD, or Doctorate will not be considered.
- 2 - 5 of relevant pharmaceutical experience in Clinical Development; specifically with Clinical Trials
- Strong experience in leading data cleaning, data review, query resolution, document review, and literature searches.
- Strong experience reviewing/developing documentation such as: study protocols, clinical development plans, investigative brochures, and TFLs.
- Ability to communicate effectively, work independently; demonstrates strong organizational and negotiation skills
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Machine operator
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Horizon Ventures Logan, United StatesDo you enjoy keeping everything running smoothly? Perfect, then we are looking for YOU as a Machine Operator (m/f/d) for our client in the Kronach district. · Your responsibilities: · Operating machines · Monitoring ongoing production · Visual inspection and proper packaging of p ...
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Director, Clinical Monitor, Vaccines
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Pfizer Cambridge, United States Full timeROLE SUMMARY · The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies a ...
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Spaulding Rehabilitation Hospital Cambridge, United StatesJob Description - Pharmacist, Per Diem Job Description Pharmacist, Per Diem Description As an integral member of the patient care team, this registered professional is responsible for the preparation and dispensation of all medication at Spaulding Rehabilitation Network. Collabo ...
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Mechanical Engineer
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Randstad USA Cambridge, United StatesImmediate need for a Mechanical Engineer for a leading medical device/equipment manufacturer in Cambridge, MA. Mid-senior level candidates with a strong background in medical device design and development are strongly desired. · Qualifications: · • Education: Bachelor's Degree or ...
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Senior Environment Health Safety Specialist
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Insight Global Cambridge, United StatesRequired Skills and Experience · University degree or equivalent · 3-5 years of experience in health, environment, and safety · Experience working in a highly regulated environment (bio/medical/pharma) or in facility maintenance · Nice to Have Skills and Experience · OSHA Certif ...
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Project manager
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LTTS Cambridge, United StatesJob Description & Skill Requirement: · You will be responsible for driving software projects under medical devices domain. · Aware of ISO 13485 standards. · You will collaborate with team members, senior leaders, and stakeholders within the businesses, gaining agreements o ...
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Health Safety Environment Supervisor
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Insight Global Cambridge, United StatesMust Haves: · University degree or equivalent · 3-5 years of experience in health, environment, and safety · Experience working in a highly regulated environment (bio/medical/pharma) or in facility maintenance · Pluses · OSHA Certified · Any environmental certifications · Day to ...
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Health Safety Environment Supervisor
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Insight Global Cambridge, United StatesRequired Skills & Experience · University degree or equivalent 3-5 years of experience in health, environment, and safety Experience working in a highly regulated environment (bio/medical/pharma) or in facility maintenance · Nice to Have Skills & Experience · OSHA Certified Any e ...
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CNA/HHA/Caregiver Needed in Cambridge, MA
2 weeks ago
Babette Home Care Cambridge, United States Part timeCompany Description · Babette Home Care is a unique and dependable personalized first-class approach to home care. Our goal is to keep patients safe, happy and independent in their own homes. Our services cater to each individual's unique needs providing top quality care. · Role ...
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Technician B, Environment, Health and Safety
5 days ago
MIT Cambridge, United States Full timeJob Description · TECHNICIAN B, ENVIRONMENT, HEALTH AND SAFETY (EHS) , Environment, Health and Safety Office- Industrial Hygiene Program-Asbestos Program, to assist with laboratory or research work and operate experimental and technical equipment under the supervision of scientif ...
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Medical Director
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ONO PHARMA USA Cambridge, United StatesMedical Director level role that provides strategic oversight for clinical development programs and associated clinical trials. · Ensures the highest medical integrity and conduct of clinical studies in the execution and completion of the clinical and regulatory components of the ...
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Associate Director, Sales Operations
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Vericel® Corporation Cambridge, United StatesVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing sales operations professional looking to join and contribute to a commercial stage company with an established portfolio of u ...
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Emergency Department Medical Technician
2 weeks ago
Allina Health Cambridge, United States Part timeDescription · :Within scope of medical certification, independently provides direct and indirect patient care. This includes, but not limited to phlebotomy, EKG, wound preparation, applying splints, obtaining specimen and the fitting and educating of durable medical equipment. P ...
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Associate Director, Publications
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Apnimed Cambridge, United StatesApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our ...
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Director of Contract Revenue Operations
1 week ago
Vinfen Cambridge, United StatesSchedule: Monday - Friday 9 am to 5 pm · Salary: To be determined · The Director of Contract Revenue Operations reports to the VP of Finance and Revenue Operations of Vinfen, and is responsible for the timely and efficient billing, collection, and reporting of all state contrac ...
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Front Desk Manager
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Sonesta Hotels Cambridge, United States Full timeDescription · Always Adheres to Stay Safe with Sonesta safety standards. · Ensures that quality services are rendered in meeting guest needs. · Enforces standard procedures for the acceptance, security and return of guest lost and found items. · Provides feedback on individual p ...
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Director of Contract Revenue Operations
3 weeks ago
Vinfen Cambridge, United StatesSchedule: Monday - Friday 9 am to 5 pm · Salary: To be determined · The Director of Contract Revenue Operations reports to the VP of Finance and Revenue Operations of Vinfen, and is responsible for the timely and efficient billing, collection, and reporting of all state contract ...
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Medical Director Consultant
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Stratacuity: Proven Scientific Placement Cambridge, United States Part timeLocation: Cambridge, MA (Hybrid) · Science/ Focus: Biologics · Job Overview: This role is for an experienced Hematology/Oncology M.D. to take a pivotal role, driving the revolutionary clinical development of transformative cancer treatments. · Primary Job Responsibilities: · Lead ...
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Manager/Senior Manager of Operations
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PharmaLogics Recruiting Cambridge, United States Full timePosition Summary · We are a discovery-stage biotechnology company backed by top-tier life science investors leveraging insights in RNA biology to discover and develop new therapeutics for high unmet needs indications across multiple disease areas including oncology and neuromuscu ...
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Clinical Supply Chain, Supply Planner
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ProClinical Cambridge, United StatesClinical Supply Chain, Supply Planner - Contract - Cambridge, MA · Proclinical is seeking a dedicated and detail-oriented Clinical Supply Chain Planner. · Primary Responsibilities: · The successful candidate will be responsible for supporting various programs and protocols, mana ...
Clinical Research Physican/Medical Monitor - Cambridge, United States - Redbock - an NES Fircroft company
Description
A mid-sized bio-pharmaceutical company in the greater Boston area is looking to add a Medical Monitor to their team. Our client is working on accelerated timelines for a program and they are experiencing an immediate need for hands-on support. This consultant will serve as a scientific resource for study teams, departments, and others as needed.
This is a fully remote 9 month assignment through February 2025 with potential for extension. Our client needs someone to get started ASAP.
Duties & Responsibilities:
Qualifications:
