Senior Clinical Data Manager
2 months ago
- The Clinical Data Manager will be responsible for the clinical data management (CDM) activities for the entire life cycle of Oncology Pivotal Phase III trial(s) from protocol concept review through completion of the clinical study report.
- Proactively oversee CDM execution of CRO outsourced pivotal trial(s).
- Accountable and responsible for ensuring data quality and timeliness of study related CDM deliverables.
- Coordinates study start-up activities; review and sign off of eCRF, eCRF completion guidelines, Data Validation Specifications, data management plan (DMP), data review guidelines (DRG); coordinates database live activities; tests/accepts clinical database for EDC studies.
- Conducts peer review, develops and implements QC plan for CDM deliverables from internal and functional service providers (CROs), including but not limited to: eCRF design, Data Validation Specifications, Database build, UAT and validation documentation.
- Data review and cleaning to ensure data quality. Executes DRGs and manages query flow.
- Data imports/exports with external data providers.
- Coordinates Medical coding and SAE reconciliation efforts.
- Generates and reviews CDM metrics for study management team (SMT); identifies and communicates data trends to SMT; reconciles safety and other external data with CRF data; reviews any study-specific quality objectives and ensures these are reflected in the study Data Management Plans.
- Manages data entry personal and manages CRF paper tracker in some instances
- Identifies process gaps in CDM area and makes recommendations for improvement. Creates and maintains SOPs related to CDM activities.
- Develops/maintains CDM timelines for assigned studies with input from study team and all relevant functions.
- Effectively manages assigned projects by adhering to established timelines and deliverables.
- Reviews all required Data Management documentation for projects.
- Assists in the development of quality objectives for each project; Adoption and implementation of established standards and processes; and identifies areas where new standards are needed.
Requirements:
- Full Knowledge of the drug development, study conduct processes, regulations related to Data Management and clinical research such as CFR Title 21, ICH Guidelines, EU Directives, GCP and relevant regulatory compliance.
- Exhibits strong leadership, communication (written and oral), interpersonal communication skills, logical thinking, attention to detail and problem-solving abilities.
- Works well in a cross functional team environment with and ability to work in a team to meet timelines and achieve deadlines.
- Excellent project management, organizational, prioritization, and multitasking skills. Demonstrated ability to work independently.
- Experience with clinical data management systems, proficiency in EDC/RDC (e.g. RAVE, Inform, Oracle Clinical), experience in basic SAS / SQL programming, and an understanding of CDISC, SDTM and other industry standards, experience with reporting tools like J-review is a plus.
- CDM Certification (CCDM) is desirable.
- Bachelor's degree or 6+ years pharmaceutical experience, including data management of Global Pivotal clinical trials.
- Oncology, CRO, CLINICAL TRIALS, CDM, CLINICAL DATA MANAGEMENT.
We have other current jobs related to this field that you can find below
-
Physical Therapist
3 weeks ago
Peabody, Massachusetts, 01960, Essex County, MA, United States Brooksby Village by Erickson Senior Living Full timeLocation:Brooksby Village by Erickson Senior LivingBrooksby Village is a beautiful 90-acre continuing care retirement community located just 20 minutes from Boston in Peabody, Massachusetts. We’re part of a growing network of communities developed and managed by Erickson Senior Living, a national provider of senior living and health care with campuses in...
-
Social Worker Clinical Manager
2 months ago
Boston, Massachusetts, Massachusetts, 02112, Suffolk County, MA, United States Beth Israel Deaconess Medical Center Full timeJob Type: RegularTime Type: Full timeWork Shift: Day (United States of America)FLSA Status: ExemptWhen you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.Essential Responsibilities:• Coordinates social work practice for accountable areas of practice. Works with interdisciplinary leadership in...
-
Senior Engineer I
2 months ago
Massachusetts, United States Novo Nordisk Full timeAbout the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the hub for all manufacturing-related activities for GalXCTM and GalXC-PlusTM investigational therapeutics developed from Novo Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December...
-
Senior MRI Technologist Senior
5 days ago
Boston, Massachusetts, 02298, Suffolk County, MA, United States Boston Children's Hospital Full timeNew hires with more than 1 year of experience may be eligible for a $15,000 sign-on bonus.New hires with less than 1 year of experience may be eligible for a $10,000 sign-on bonus.The Senior MRI Technologist is responsible for the following:Performs the more complex MRI procedures on a scheduled and emergency basis.Reviews and evaluates requisitions for MRI...
-
Senior Manager, Corporate Relations
2 weeks ago
Massachusetts, United States Root Capital Inc. Full timetendersglobal.net Reports To: Senior Director, Institutional Partnerships & Philanthropy Job Type: Full-Time Employment Region: United States Location: US Remote, MA Cambridge Start Date: Immediate Contact: Please apply by using the company site About Root Capital Agriculture is the key to unlocking a better future for billions of people. But while...
-
Senior Manager, Corporate Relations
2 weeks ago
Massachusetts, United States Root Capital Inc. Full timeReports To: Senior Director, InstitutionalPartnerships & PhilanthropyJob Type: Full-Time EmploymentRegion: United StatesLocation: US Remote, MA CambridgeStart Date: ImmediateContact: Please apply by using the companysiteAbout Root CapitalAgriculture is the key to unlocking a better future for billionsof people. But while rural families sustain the world,...
-
Senior MRI Technologist
5 days ago
Boston, Massachusetts, 02298, Suffolk County, MA, United States Boston Children's Hospital Full timeNew hires with more than 1 year of experience may be eligible for a $15,000 sign-on bonus.New hires with less than 1 year of experience may be eligible for a $10,000 sign-on bonus.The Senior MRI Technologist is responsible for the following:Performs the more complex MRI procedures on a scheduled and emergency basis.Reviews and evaluates requisitions for MRI...
-
Senior Manager, Quality Control
2 days ago
Massachusetts, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...
-
Employee Health Nurse Practitioner
4 weeks ago
Hingham, Massachusetts, 02043, Plymouth County, MA, United States Linden Ponds by Erickson Senior Living Full timeLocation:Linden Ponds by Erickson Senior LivingLinden Ponds is a beautiful 108-acre continuing care retirement community located just 24 miles from Boston on the South Shore in Hingham, Massachusetts. We’re part of a growing network of communities developed and managed by Erickson Senior Living, a national provider of senior living and health care with...
-
Senior Manager of GTM Business Systems
2 months ago
Boston, Massachusetts, United States Catapult Sports Full timeWe are looking for a talented and inquisitive Senior Manager, GTM (Go to Market) Business Systems, whose drive for learning and determination for continuous improvement align with our ambitious, fast-growing and transforming company. Based in Boston, you will lead the design, implementation, and optimisation of business systems supporting our sales,...
-
VP, Chemistry, Manufacturing and Controls
1 month ago
Massachusetts, United States Replimune Group Full timeOverview The Vice President of CMC is responsible for the leadership and management of Replimune’s Manufacturing function at the Framingham site and the supporting global Process Development function. The role holder will oversee all aspects of drug substance and drug product development and scale up, technology transfer, clinical and commercial...
-
Clinical Nutrition Manager III
6 days ago
Salem/Massachusetts/US Sodexo Full timeUnit Description: Grow your career and develop a team that shares your desire to make a difference. Sodexo is seeking a Registered Dietitian for a Clinical Nutrition Manager III position at Salem Hospital in Salem, MA. MGB Salem is a 410-bed Level III Trauma Center serving patients as part of the Mass General Brigham system. The successful candidate...
-
Clinical Laboratory Technologist- Microbiology
1 month ago
Massachusetts, United States Labcorp Full time$10,000 sign on bonus (external candidates only)Are you an experienced Clinical Lab Professional? Are you looking to looking to embark on a new challenge in your career, or start your career in Clinical Lab Science? If so, LabCorp wants to speak with you about exciting opportunities to join our team at Tufts Medical Center in Boston, MA. In this position you...
-
Senior Product Manager, Adtech
3 days ago
Cambridge, Massachusetts, United States KAYAK Full timeKAYAK, part of Booking Holdings (NASDAQ: BKNG), is the worldâs leading travel search engine. With billions of queries across our platforms, we help people find their perfect flight, stay, rental car, cruise, or vacation package. Weâre also transforming the in-travel experience with our app and new accommodation software. For more information,...
-
Certified Medical Assistant
5 days ago
Hingham, Massachusetts, 02043, Plymouth County, MA, United States Linden Ponds by Erickson Senior Living Full timeLocation:Linden Ponds by Erickson Senior LivingLinden Ponds is a beautiful 108-acre continuing care retirement community located just 24 miles from Boston on the South Shore in Hingham, Massachusetts. We’re part of a growing network of communities developed and managed by Erickson Senior Living, a national provider of senior living and health care with...
-
Licensed Practical Nurse
1 month ago
Hingham, Massachusetts, 02043, Plymouth County, MA, United States Linden Ponds by Erickson Senior Living Part timeLocation:Linden Ponds by Erickson Senior LivingLinden Ponds is a beautiful 108-acre continuing care retirement community located just 24 miles from Boston on the South Shore in Hingham, Massachusetts. We’re part of a growing network of communities developed and managed by Erickson Senior Living, a national provider of senior living and health care with...
-
Registered Nurses
1 month ago
Hingham, Massachusetts, 02043, Plymouth County, MA, United States Linden Ponds by Erickson Senior Living Part timeLocation:Linden Ponds by Erickson Senior LivingLinden Ponds is a beautiful 108-acre continuing care retirement community located just 24 miles from Boston on the South Shore in Hingham, Massachusetts. We’re part of a growing network of communities developed and managed by Erickson Senior Living, a national provider of senior living and health care with...
-
Senior Manufacturing Manager
2 months ago
Massachusetts, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...
-
LPN Med Care Manager
2 months ago
Sunrise of Braintree - 618 Granite Street Braintree, Massachusetts 02184 United States Sunrise Senior Living Full timeOverviewThe LPN Medication Care Manager is responsible for providing the highest degree of quality care and services by administering medication and treatments in a safe organized manner. Responsibilities include but are not limited to administration of medications, documentation of medication administration, conducting SHUs, and providing resident care...
-
LPN Med Care Manager
3 days ago
Sunrise of Braintree - 618 Granite Street Braintree, Massachusetts 02184 United States Sunrise Senior Living Full timeOverviewThe LPN Medication Care Manager is responsible for providing the highest degree of quality care and services by administering medication and treatments in a safe organized manner. Responsibilities include but are not limited to administration of medications, documentation of medication administration, conducting SHUs, and providing resident care...
