Sr. / Clinical Trial Specialist (Clinical)
Company: ProPharma Group
Location: Durham
Posted on: January 26, 2023
|
|
Job Description:
Company Description
ProPharma Group is an industry leading, single source provider for
regulatory compliance, pharmacovigilance, and medical information
services across the full development lifecycle for pharmaceutical,
biotechnology, and medical device companies. Operating around the
world with offices in Australia, Canada, Germany, Japan, the
Netherlands, Sweden, United Kingdom, and the United States,
ProPharma Group's fully integrated service offerings will provide
clients with a comprehensive suite of global support services that
are required to be competitive in today's dynamic markets. We build
successful long-term relationships with clients by providing
leading industry knowledge, experience, and proven processes.
Job Description
Essential Duties and Responsibilities:
--- Work with the Clinical Trial Managers, and other study team
members, to educate and train study sites, or study teams, as
needed.
--- Work with study sites to obtain required regulatory
documentation during most phases of the study.
--- May prepare, manage and track study-specific contracts,
budgets, and clinical study payments in applicable systems.
--- Completes loading and QC of TMF documents to the appropriate
system, or central mailbox, as needed to support the
department.
--- Provides document management support to clinical teams for
study maintenance and other periods of high volume document flow as
assigned.
--- Manage and track clinical and non-clinical supplies.
--- Track and prepares study information utilizing databases,
spreadsheets, and other tools (i.e. SharePoint, SmartSheet,
etc).
--- Manage and distribute study-related materials to all study
sites as requested.
--- Ability to work cross-functionally with multiple
departments.
--- Enter all new study site or ongoing information into eTMF and
any other applicable Clinical Trial Operations system, as
applicable.
--- Participates in TMF SOP reviews and ensures TMF QC process is
managed across all trials.
--- Collaborate on and continuously look for opportunities to
streamline and improve processes.
--- Assist in training or mentoring new employees on the CTS
activities or other CTS study-related processes.
--- Other study-related administrative duties as needed.
--- Adhere to all required Standard Operating Procedures
(SOP's)
Qualifications
Qualified candidates must have:
--- A minimum of 4 years experience working with clinical
trials.
--- Worked across at least two phases of studies.
--- 2 years eTMF uploading and QC experienced required.
--- Strong written and verbal skills.
--- Ability to work as part of a team comprised of internal
employees, contractors and managers.
--- Ability to multitask and take on various projects.
--- Must be able to prioritize and manage a large volume of work
and show attention to detail.
--- Ability to work with self-discipline, good judgment and
independence in a dynamic office or remote setting.
--- Excellent written, verbal communication skills are required, as
is computer proficiency.
--- Excellent keyboard skills, with experience using Microsoft
Office (Word, Excel, PowerPoint) applications to prepare charts,
tables, forms, reports, and presentations.
--- Experience with e-mail and calendar programs. Flexibility with
respect to working hours based on operational need.
Qualifications
Qualified candidates must have:
--- A minimum of 4 years experience working with clinical
trials.
--- Worked across at least two phases of studies.
--- 2 years eTMF uploading and QC experienced required.
--- Strong written and verbal skills.
--- Ability to work as part of a team comprised of internal
employees, contractors and managers.
--- Ability to multitask and take on various projects.
--- Must be able to prioritize and manage a large volume of work
and show attention to detail.
--- Ability to work with self-discipline, good judgment and
independence in a dynamic office or remote setting.
--- Excellent written, verbal communication skills are required, as
is computer proficiency.
--- Excellent keyboard skills, with experience using Microsoft
Office (Word, Excel, PowerPoint) applications to prepare charts,
tables, forms, reports, and presentations.
--- Experience with e-mail and calendar programs. Flexibility with
respect to working hours based on operational need.
Additional Information
Keywords: ProPharma Group, Durham , Sr. / Clinical Trial Specialist (Clinical), Healthcare , Durham, North Carolina
Click
here to apply!
|