Clinical Trial Manager
Company: Beacon Hill Staffing Group - Pharma
Location: Quincy
Posted on: February 15, 2021
|
|
Job Description:
SUMMARY: Responsible for operational aspects of planning and
management of site performance in accordance with departmental
expectations. May act as primary liaison between in-house CRAs,
field based CRAs and the Clinical Project Manager (CPM). Supports
and assists Clinical Project Managers in operationalizing multiple
clinical research studies. RESPONSIBILITIES: Participates in CRA
project-specific training. Supports preparation and may develop
materials related to the training and presentations for
Investigator Meetings. Facilitates CRA project meetings. Assist in
the oversight of monitoring staff including the tracking and review
of monitoring trip reports and escalate any trends with respect to
data quality or study conduct to the appropriate CPM. Track and
report on progress of the study including site activation, patient
enrollment and monitoring visits. Ensures that all sites are
provided supplies in accordance with study start-up expectations.
Identify potential risks to the enrollment targets based on
feasibility analysis in collaboration with the CPM. Develop
PSV/SIV/IMV and other training tools and training materials in
support of the project. Assist in the review of CRO and other third
party vendors invoices to ensure that work is performed in
accordance with scope of work. Ensure that monitoring visits are
performed in accordance with the protocol, monitoring plan, and
applicable SOPs. Responsible for the development of any mass site
communication as appropriate. Responsible for operationalizing
clinical protocols at the site level and ensuring appropriate SOPs
are being followed for each process, depending on the study.
Participate in eCRF in User Acceptance Testing (UAT) and the
creation of eCRF completion guidelines, and ensuring site level
access to eCRFs throughout the conduct of a study. Work with CRAs
in proactively maintaining / up-dating essential documents as
required, to ensure compliance with protocol and regulations.
Contact sites as needed for data entry/data quality concerns and
alert CRA of any issues prior to the next scheduled monitoring
visit. Assist with study start-up activities including development
of the first draft of the ICF. Assist with the review of protocol,
protocol amendments, ICF and CSR documents as required. Provide
active mentorship of CTA staff to build talent across the
department. Agenda distribution & minute taking for internal study
team meetings. Up to 20% domestic and/or international travel may
be required. QUALIFICATIONS: Bachelors degree or nursing
qualification is required. Scientific/health care field preferred,
but not required. Experience (2+ years) working in clinical
research within a pharmaceutical company or CRO or similar
organization. Requires strong attention to detail in composing and
proofing materials, establishing priorities, scheduling and meeting
deadlines. Must be able to work in a fast paced environment with
demonstrated ability to juggle multiple competing tasks and
demands. Ability to work successfully within a cross-functional
team. Strong knowledge of applicable computer and project
management software packages. Excellent written and oral
communication skills. Ability to interact with investigators,
vendors, and internal colleagues. Knowledge of current regulatory
requirements and guidelines governing clinical research. Ability to
complete tasks to deadlines and resolve/elevate problems in a
timely manner.
Keywords: Beacon Hill Staffing Group - Pharma, Quincy , Clinical Trial Manager, Healthcare , Quincy, Massachusetts
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Healthcare JobsPsychiatric LPN Job Description: Responsibilities: ul Responsible for planning and providing support and medical and nursing care Company: KA Recruiting, Inc. Location: Concord Posted on: 02/26/2021 Travel RN-Telemetry - South Weymouth, MA (RN #) Description: ul li RNnetwork has an excellent travel opportunity for a provider experienced in the following specialty: RN-Telemetry. This opportunity will be available Company: RNnetwork Location: Weymouth Posted on: 02/26/2021 Physician Assistant Cardiac Surgery in NH - Experienced CVT PA needed Description: A Hospital system in Southern New Hampshire is looking for a CVT Physician Assistant with vein harvesting experience to join their team. This is a Monday - Friday permanent position offering a 4 day work (more...) Company: CompHealth Location: Concord Posted on: 02/26/2021 Emergency Medicine Physician Job near Concord, New Hampshire (j-5740) Description: A progressive facility in New Hampshire is in need of an Emergency Medicine physician. Area is great for outdoor activities, ski slopes, biking in one of Company: HDA MD Staff Location: Concord Posted on: 02/26/2021 NP / Registered Nurse / New Hampshire / Any / NP-Family Job Description: About our Client: Our client is the third largest full service clinical diagnostic laboratory in the United States providing testing and related service to physician's offices, clinics hospitals. They (more...) Company: All Medical Personnel Location: Concord Posted on: 02/26/2021 RN - Registered Nurse - Emergency Room (RN #) Description: RN needed for ER in South Weymouth, MA CoreMedical Group has hundreds of exciting and rewarding travel assignments throughout the country for Travel Allied Professionals Company: CoreMedical Group Location: Weymouth Posted on: 02/26/2021 Medical Intensive Care - Travel MICU RN Description: Medical Intensive Care Nurse MICU Nationwide Travel Nurse Assignments Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are (more...) Company: HealthCare Traveler Jobs Location: Concord Posted on: 02/26/2021 Licensed Health Insurance Agent - Sell Anthem, Teledoc, UHC, and more Description: Job Description This role requires the candidate to currently have a Residential Company: ASSURANCE Independent Agents Location: East Providence Posted on: 02/26/2021 Licensed Health Insurance Agent - Seize SEP With Us, Inbound Leads Description: Job Description This role requires the candidate to currently have a Residential Company: ASSURANCE Independent Agents Location: East Providence Posted on: 02/26/2021 Licensed Therapist for Online Counseling Description: Private practice with no doors and no overhead. Join the world's largest online counseling platform. We provide the marketing, the technology, and the additional income. You provide the professionalism, (more...) Company: BetterHelp Location: Concord Posted on: 02/26/2021 |