- Review and input into relevant clinical trial documentation (e.g. protocol, Project Operational Plan, RAID log, Monitoring Plan) as per Scope of Work
- Create and review advanced data strategies (incl. data flow)
- Is responsible to initiate Data Management timelines
- Is responsible to plan, manage and request resources for assigned projects
- Prepare and/or review relevant trial level DM documentation (e.g. CRF design, DMP, SDS, CCGs, validation specifications, data transfer specifications ...)
- Prepare and/or review specifications for data listings, study specific status/metrics reports
- Prepare and/or review eCRF/CRFs, clinical trial database design and validation check programming
- Oversee and/or lead UAT and completion of associated documentation
- Coordinate DB set-up and upgrades, including review of eCRFs, database design and validation check requirements
- Prepare and conduct study specific EDC training for study team
- Oversee and/or lead data listing review and query management
- Oversee and/or lead the management and reconciliation of third-party data and SAEs
- Oversee and/or lead the receipt, management, entry, QC and review of local laboratory reference ranges
- Provide and oversee DM input into protocol deviations as needed
- Oversee and/or lead DB freeze/lock related activities
- Oversee and/or lead the archiving activities for study data and DM documentation activities
- Support identification of the trends in the study assigned (eg: sites not compliant with data entry, queries resolution, ...) and inform the PL accordingly.
- Lead assigned study or activities and where required, actively shadow study lead and deputize Lead CDM
- Lead and participate in internal and external team communication
- Ensure maintenance and filing of study documents
- Follow up and escalate any data quality, budget, timelines and resource issues
- Responsible for financial management of assigned projects, including revenue recognition, changes in scope, including liaison with PL/ Finance as needed
- Lead and participate in client/vendor meetings and cover DM aspects
- Provide input and estimates for budget requirements and resource; perform ongoing budget review
- Ensure appropriate reporting of project status to internal and external stakeholders
- Onboard extended DM team members
- Ensure timely and accurate entry into relevant clinical study or research project/ departmental reporting systems (e.g. status, metrics, timesheet)
- Maintain up to date knowledge for DM techniques, procedures and tools
- Participate in departmental presentations and process improvement initiatives and visibly contribute to department development
- Participate in and attend bid defense meetings for business development
- Make recommendation for DM trainings on techniques and procedures; develop, review & deliver trainings
- Train and/or mentor DM team or department members
- Take on a formal SME role and provide expertise
- Develop, review and deliver relevant departmental SOP/ Process Training
- Prepare for, participate in and respond to audits where assigned as the Lead Clinical Data Manager
- Bachelor's degree level qualification or equivalent experience is preferred
- 5 or more years of experience in clinical trial activities of clinical data management with experience of leading trials
- Good organizational and problem-solving skills
- Good oral and written communication and interpersonal skills
- Good understanding of ICH/GCP and applicable regulations
- Experience working with EDC systems (e.g. Rave, Viedoc, Veeva)
- Experience in using Microsoft office and understanding of other reporting software
-
Team Leader Energy Data Management
3 weeks ago
Apex Ventures White Oak, United StatesAt White Oak, we have a team of passionate individuals who are dedicated to meeting the needs of our customers. Together, we ensure the safe supply of energy and drinking water to the Rhineland region. We are always looking towards the future, as a forward-thinking company, we ar ...
-
Data Manager
2 weeks ago
Wake County Public Schools Cary, United StatesOverview: · POSITION TITLE (Oracle title) · DATA MANAGER · WORKING TITLE · Data Manager-Alternative Education · SCHOOL/DEPARTMENT · Alternative Education and Extended Learning Programs · LOCATION · Crossroads II, Cary, NC · PAY GRADE · Noncertified Grade 22 · FLSA STAT ...
-
Master Data Manager
3 weeks ago
Omada Search Cary, United StatesThe Global Master Data Manager leads the development and management of master data and its related processes. This role will be responsible for improving the quality and protecting sensitive data and information assets. This position will be the global process owner for master da ...
-
Master Data Manager
1 week ago
Omada Search Cary, United StatesJob Description · Job DescriptionThe Global Master Data Manager leads the development and management of master data and its related processes. This role will be responsible for improving the quality and protecting sensitive data and information assets. This position will be the g ...
-
Data Governance Program Manager
2 weeks ago
MetLife Cary, United States Full timeDescription and Requirements · On MetLife's Global Technology and Operations (GTO) team, what you build here matters. We view our solutions through the eyes of the customers and are always striving to transform and simplify their experience. Whether your focus is keeping our cust ...
-
Manager-Quality and Data Management
2 weeks ago
Biogen Research Triangle Park, NC, United StatesThe Quality Assurance Sr Manager is a fully onsite role responsible for strategic leadership of the Quality Factory Team for large volume manufacturing providing operational oversight of batch production activities and evaluation, as well as providing batch acceptance decisions f ...
-
Infinity Ventures East Duke, United StatesPosition: 66122 · Team: Magna Corporate · Department: Magna International (Germany) GmbH · Employment Type: Full-time/Permanent · Locations: SAILAUF, GRAZ, Munich · About Us · At East Duke, we envision a future where everyone can live and move without limitations. That's why ...
-
Merchant (m/f/d) for master data management
3 days ago
Blue Horizon Solutions Durham, United StatesWe are a medium-sized expanding specialist wholesaler for building technology and plant construction with headquarters in Ingolstadt. To strengthen our team in Ingolstadt, we are currently looking for a commercial specialist for our master data management (m/f/d). · Your benefit ...
-
Licensed Salon Manager
1 day ago
Sport Clips Cary, United States Full time$1,000 Sign On Bonus · Sport Clips Haircuts is Hiring Managers Do What You Love. Love What You Do. · JOB DESCRIPTION · Our salon is looking for talented salon managers who are passionate about cutting hair and making their clients look great Our team is dedicated to exceptional c ...
-
Hair Stylist
1 week ago
Sport Clips Cary, United StatesSport Clips Haircuts is Hiring Hair Stylists Do What You Love. Love What You Do. · JOB DESCRIPTION · Our location at Parkside Town Center in Cary is busy and looking for NC Licensed Cosmetologists to join our salon team. We are looking for Assistant Managers as well. We need more ...
-
Sales Representative
1 week ago
SYSCO Cary, United States Full timeCompany: · US1167 FreshPoint Raleigh, Division of FreshPoint North Carolina, Inc.Zip Code: · 27560Employment Type: · Full TimeTravel Percentage: · Up to 50%COMPENSATION INFORMATION: · The pay range provided is not indicative of Sysco's actual pay range but is merely algorithmic ...
-
Mobile Tech I
1 week ago
Penske Truck Leasing Cary, United States Full timeExciting New Road Tech Program · 204 trans air dr morrisville nc 27560 Position Summary: · Penske Mobile Technician I will generally assist in the repair and diagnosis of major components or remove/replace major components at the direction of the PFM Asset Supervisor. Expectation ...
-
10-month Dean's Secretary
3 weeks ago
Crystal Lake Community High School D155 Cary, United StatesCary-Grove High School, within Community High School District 155, has an anticipated opening for a 10-month Dean's Secretary. The pay scale begins at $21.49 and placement on salary schedule will be in accordance with the current negotiation agreement. Please review a general job ...
-
Diesel Technician/Mechanic II
2 weeks ago
Penske Truck Leasing Cary, United States Full time204 trans air drive morisville, nc 27560 What's the Job? · Ready to move your career forward? As a Technician at Penske, you'll do exactly that. Here, you'll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles in the indu ...
-
Mobile Technician II
2 days ago
Penske Truck Leasing Cary, United States Full time204 Trans Air Drive Morrisville NC 27560. · What's the Job? · Ready to move your career forward? As a Technician at Penske, you'll do exactly that. Here, you'll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles in the i ...
-
Diesel Technician/Mechanic III
1 week ago
Penske Truck Leasing Cary, United States Full time204 trans air dr morrisville nc 27560 What's the Job? · Ready to accelerate your career while helping our customers move forward? As a Technician at Penske, you'll do exactly that. Here, you'll do preventative maintenance and minor repairs on the newest and best maintained fleet ...
-
Diesel Technician/Mechanic III
1 week ago
Penske Truck Leasing Cary, United States Full time204 trans air dr morrisville nc 27560 What's the Job? · Ready to accelerate your career while helping our customers move forward? As a Technician at Penske, you'll do exactly that. Here, you'll do preventative maintenance and minor repairs on the newest and best maintained fleet ...
-
Diesel Technician/Mechanic III
1 week ago
Penske Truck Leasing Cary, United States Full time204 trans air dr morrisville nc 27560 What's the Job? · Ready to accelerate your career while helping our customers move forward? As a Technician at Penske, you'll do exactly that. Here, you'll do preventative maintenance and minor repairs on the newest and best maintained fleet ...
-
Diesel Mechanic/Technician I
3 weeks ago
Penske Truck Leasing Cary, United States Full time204 trans air dr morrisville nc 27560 What's the Job? · Ready to move your career forward? As an experienced Technician at Penske, you'll do exactly that. Here, you'll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles i ...
-
Outbound Loader
1 week ago
SYSCO Cary, United States Full timeCompany: · US1167 FreshPoint Raleigh, Division of FreshPoint North Carolina, Inc.Zip Code: · 27560Minimum Level of Education: · High School or EquivalentMinimum Years of Experience: · 0-1 YearsEmployment Type: · Full TimeTravel Percentage: · 0COMPENSATION INFORMATION: · The pay ...
senior clinical data manager - Morrisville, NC, United States - Aixial Group
3 weeks ago
Description
Sourcing Statement
You are applying to be part of the Aixial Group Talent Pool. We are not currently recruiting for this role but we are building a pipeline for an upcoming Senior CDM role in the US. If you would like to be considered for this position in the near future, then please submit your CV. In order to expedite the process, we will be proceeding with screen calls to gather further information about your experience.
The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies.
The Aixial Group occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data.
This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.
We are currently looking for an enthusiastic and talentedSenior Clinical Data Manager. This role is home-based anywhere on the
East Coast, US.
Purpose
Carry out the required data management tasks on clinical studies or research projects within the clinical trial environment.
Perform the role of Lead Data Manager on assigned studies with responsibility for the timely delivery of set-up, conduct and high quality final locked databases in accordance with the budget, Aixial's contractual obligations and Standard Operating Procedures.
Responsibilities
Perform the following tasks, independently as the Lead Clinical Data Manager.
Study Setup
Study Conduct & Close-out
Study Leadership
General
Required skills and qualities
Technical skills
Languages
Fluent English:
Read, Written, Spoken
The above job description in no way states or implies these duties are the only duties performed by this employee.
The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.
For more information on Aixial Group Recruitment and consideration for other opportunities, please review the recruitment statement on our careers page -
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Aixial Group HR or Talent Acquisition Manager.
Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.
