VIEW JOBS9/22/2018 12:00:00 AM2018-12-21T00:00Research Data Manager (EDC / SAS)
Location: Watertown, MA
Duration: 6 months
This position requires proven data management knowledge and skills in a variety of settings from pivotal to complex and multi-vendor and therapeutic and non-interventional studies. The Research Data Manager leads activities on multiple projects and directs the work for other assigned resources. They are able to work with minimal supervision individually or as part of a project team. This position requires time and resource management skills, and understands critical milestones and predecessors leading to significant project deliverables, and interdepartmental product hand offs.
Essential duties and responsibilities include the following. other duties may be assigned.
In addition to normal data management activities, the Research Data Manager performs the following duties for a substantial portion of the time:
- Assists or develops data management plan for study design and database content development.
- Configures the data content collection in the EDC system per the research protocol, and may oversee or peer review the configuration for other DMs.
- Responsible for eCRF testing, edit check development and configuration, documentation, and user training prior to going live.
- Per project needs, programs specific reports in the EDC system or using SAS, writes reports specifications as required by the project’s needs.
- Assists in the dissemination of results/findings and maintains communication patterns with physicians, hospital staff and study sponsors.
- Acts as liaison with all study team members and other functional groups on all levels, on technical requirements for database development and data quality within a study.
- Oversees data management activities to ensure that the protocol and statistical expectations are understood, timelines are met and communications remain open.
- Work cooperatively and constructively to develop effective solutions to operational data management problems.
- Actively contributes to the review of working practices and data management SOP’s.
- Demonstrates GCDMP knowledge and practices.
Education and/or experience
Bachelor's degree (B.A./B.S.) in social or biological science or computer science plus 5 years research experience and at least 3 or more years of significant data management experience; or an MPH or Master's degree in a related field and two plus years of significant data management experience; or equivalent combination of education and directly related experience; Prior SAS programming experience and/or supervisory experience/training preferred;
Knowledge, skills and abilities:
Good communication, organization and writing skills, ability to coordinate and monitor the quality of research data collected; proven skills in a variety of data management software such as EDC, SAS, and proficiency in Microsoft Office applications. Previous EDC programming experience strongly preferred.
Skills: EDC, SAS, eCRF
VIEW JOBS9/19/2018 12:00:00 AM2018-12-18T00:00New England Research Institutes (NERI) was founded in 1986 and has grown to become a research organization with a global reputation for high-quality research, innovative thinking, and the use of state-of-the-science tools and techniques. NERI continues to be a leader in public health research, clinical trials management, epidemiology, and state of the art media and dissemination research.
NERI's clinical research group is one of the nation's leading scientific teams in the CRO arena, offering clients an unmatched depth of knowledge and experience. The team collaborates with sponsors in planning and conducting efficient domestic and international clinical trials and registries for the pharmaceutical and medical device industries, as well as observational studies to understand the natural history of a disease/condition or examine current standards of care.
This position may be located in Watertown, MA and is not remote.
The primary role of the CRA is to manage and monitor clinical sites participating in early phase clinical research studies including studies regulated by the FDA. The primary responsibilities for the position are as follows:
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Functions as the primary contact for site research staff and investigators to provide guidance; review study progress and enrollment at the site; and escalate issues to project leadership
* Collaborates with project managers and others in the development of study documents, case report forms, site staff training and procedure manuals
* CRA should be familiar with all project specific tools, such as the CTMS, Electronic Data Capture EDC and project plans in order to provide guidance and oversight to the sites
* Prepares and conducts training of new site staff
* Conducts remote and/or on-site Site Qualification Visits (SQV) and Site Initiation Visits (SIV)
* Conducts on-site routine/interim monitoring visits (IMV) to clinic sites and local/central laboratories to assess protocol compliance, SOP and GCP adherence, interview site research staff, retrain staff as needed, review regulatory documents, monitor pharmacy records, and conduct source document verification
* May conduct remote monitoring visits to verify EDC data with source documents
* Collect and review required regulatory documents and maintain Site Master Files (SMF) from site start-up through closeout
* Manage difficult sites or trouble shoots issues with underperforming sites
* Assist data management staff with the resolution of data queries
* Assist Medical Monitor in obtaining source documents related to adverse events; assist with the preparation of safety reports for the FDA and other regulatory bodies for IND trials
* Conduct on-site and/or remote closeout visits (COV)
* Write visit reports for all site visits conducted and follow up on all action items/CAPAs
To perform this job successfully, an individual must be able to perform each essential duties satisfactorily with regular and reliable attendance. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND/OR EXPERIENCE
* BS or RN and 2 years of clinical research experience, some of which includes on-site clinical research monitoring experience
* Demonstrated core understanding of medical terminology, medical records and clinical trial activities;
* Must have working knowledge of ICH-GCP guidelines, and FDA regulation as a result of clinical research experience;
* Must be able to travel at least 50%;
* Ability to monitor and coordinate multi-site research trials;
* Excellent communication, interpersonal, decision making/problem solving and organizational skills;
* Ability to work independently to initiate and implement appropriate quality control procedures;
* Proficiency with Microsoft Office Products and electronic data capture (EDC) systems;
* SOCRA or ACRP certificate is helpful, but not required.
KNOWLEDGE, SKILLS AND ABILITIES
Ability to work independently and to initiate and implement appropriate quality control procedures and to monitor and coordinate multisite research trials. Excellent oral and written communication skills. Ability to travel may be required for some positions.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit, operate computer keyboard and/or other controls requiring manual dexterity verbally communicate with others and hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
In addition to a dynamic work environment, HealthCore offers a competitive salary and a comprehensive benefits program, including a 401(k) plan; health, dental, and vision insurance; discounted fitness club membership; life, AD&D, short and long-term disability insurance coverage; tuition assistance, paid parking, and an employee stock purchase plan.
HealthCore is headquartered in Wilmington, DE, midway between New York City and Washington, DC, with offices in Andover, and Watertown MA, and Alexandria, VA. As an independently operating subsidiary of Anthem, Inc., HealthCore offers the resources of the nation's leading health benefits company in a small company environment. To learn more about us or apply for a position, please visit http://www.healthcore.com/. An Equal Opportunity Employer/Disability/Veteran
VIEW JOBS9/13/2018 12:00:00 AM2018-12-12T00:00Client is seeking a talented and highly motivated Manager/Sr. manager Clinical Supply Chain with significant expertise in supply chain management to join their CMC group in Watertown, MA. Responsible for day-to-day activities related to managing the supply of Investigational Product (IP) through all stages of clinical development including packaging, labeling and distribution as well as, supporting and advising Clinical Operations, and clinical sites on all aspects of IP and comparator products as applicable. This position reports to the Director of CMC.
Support all clinical supply activities for on-going and new clinical trials for on-time delivery, including demand forecasting, trial monitoring & resupply planning, IRT set-up and distribution activities
Design and execute packaging and labelling campaign
Support the procurement, labeling and distribution of comparators
Manage Contract Development and Manufacturing Organizations (CDMO) and provide comprehensive information about clinical supplies
Ensure continuous supply of clinical trial material for all ongoing studies within the US and ex-US locations
Ensure on time startup of new studies by having supplies available as required
Manage clinical packaging and distribution contractors
Review clinical protocols and design appropriate supply chain strategy
Design specifications for automated randomization and drug supply management systems
Oversee a variety of logistics issues, including but not limited to supply chain services, inventory control, import-export, shipment of products and third-party warehousing
Act as primary liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies
Establish measures and metrics to define manufacturing and supply chain performance and provide recommendations to Management to optimize operations both internally and externally
Work closely with Procurement and IP groups to establish supplier relationships and service agreements with cost effective distribution of Clinical Trial Material
Work collaboratively and transparently with Clinical Operations, Quality Assurance and Regulatory Affairs
Minimum Education/Skills Required:
BS degree with 7+ years’ experience in a Supply Chain Planning role in a Biotechnology or Pharmaceutical environment. MBA degree in a Supply Chain Management is a plus
Experience managing contract packaging and labeling organizations (strongly preferred)
Experience with developing risk-based supply strategy for an early to late stage clinical development programs
Thorough understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements
Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials
Experience working with QP, IVRS, IWRS, depots with global IP distribution
Excellent project management and communication skills
Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficientThe Steely GroupWatertownMA