Clinical Research Manager
Company: Labcorp Drug Development, Labcorp
Location: Durham
Posted on: May 27, 2023
Job Description:
Clinical Research Manager Remote - USA As a leading global
contract research organization (CRO) with a passion for scientific
rigor and decades of clinical development experience, Fortrea
provides pharmaceutical, biotechnology, and medical device
customers a wide range of clinical development, patient access and
technology solutions across more than 20 therapeutic areas. With
over 19,000 staff conducting operations in more than 90 countries,
Fortrea is transforming drug and device development for partners
and patients across the globe. - Did you know? - - Labcorp's
Clinical Development and Commercialization Services business is now
- Fortrea in connection with its planned spin-off from Labcorp,
which is expected in mid-2023. Fortrea's spin-off from Labcorp is
subject to satisfaction of certain customary conditions. This
spin-off will position both organizations for accelerated growth
and allow each to focus resources on distinct strategic priorities,
customer and employee needs and value creation opportunities.---As
a provider of phase I-IV clinical trial management, regulatory
guidance, patient access solutions and market access consulting,
Fortrea will partner with both emerging and large pharmaceutical,
biotechnology, device and diagnostic companies to drive healthcare
innovation and improve the lives of patients worldwide. Fortrea is
looking for problem-solvers and creative thinkers who are
passionate about breaking down barriers faced by sponsors of
clinical trials, and who are committed to helping transform the
development process to get promising life-changing ideas and
therapies to patients faster. Join us as we cultivate a workspace
where all employees have the opportunity to grow and make impacts
on a global scale. For more information and questions related to
Fortrea, please visit www.fortrea.com. Why settle for one thing
when you can have everything? Labcorp Drug Development gives you
the best two for one opportunity for career growth. Who doesn't
want twice the perks - working at one of the largest FSP CROs-and
partnering with one sponsor with a dedicated therapeutic focus. -
Our Energizing Purpose, Exceptional People and Extraordinary
Potential combined with collaborative and proactive teams offer a
great place for you to continue honing your therapeutic skills and
growing and excelling in new exciting research. Our reach is global
- extending to 60+ countries making us one of the largest FSP CROs.
So, no matter where you are located on the globe, we have an FSP
opportunity for you. - We are seeking a -Clinical Research Manager
to be accountable for execution and oversight of local operational
clinical trial activities and has ownership, oversight and impact
on local regulatory and financial compliance, at a country
operations level at the client in compliance with ICH GCP and
country regulations. The position has a significant impact on how a
country can deliver country-specific trial commitments and
objectives especially during the study. - As a customer-facing
role, this position will build business relationships and represent
Client with investigators, functional outsourcing partners and
other external partners and therefore have a significant impact on
country-level customer relationships. In this role, you will be
responsible for:
- Effectively conducting clinical studies and developing the
pipeline, while maintaining local regulatory and compliance
requirements in countries
- Making decisions independently and oversee important activities
relevant to clinical research activities in the country according
to predetermined global policies and commitments with the support,
oversight and supervision of the Country Research Director or
Therapeutic Director.
- Building and maintaining professional relationships with
investigators and other external stakeholders, with strong
communication, educational/pedagogic, diplomatic and empathic
skills
- Overseeing country commitments, compliance and training needs.
Additionally, business leadership and alignment with corporate
requires that individual has ability to lead across several
dimensions simultaneously
- Working collaboratively with Country and Regional Operations;
Pharmacovigilance, Regulatory, Global Medical Affairs and Global
Human Health internally; and with external functional outsourcing
vendors
- Coordinating and aligning the regional and broader
organization
- Building and maintaining relationships with investigators and
other external partners and promote Client's reputation
- Representing Client in Pharma industry issues and in seeking
influence in external R&D environment, in collaboration with
CRD
- Accountable for performance and compliance with assigned
protocols in relation to ICH/GCP and country regulations along with
client policies, procedures and adverse event reporting
requirements
- Proactively driving/tracking execution and performance of
deliverables/timelines/results to meet country commitments;
collaborating with local clinical operations roles; and forecasting
country needs
- Overseeing quality and compliance including training. -
Oversight of CRAs and CTCs including QC visits, Monitoring Visit
Reports, escalation of performance issues and training needs;
oversees CRMs assigned to client
- Collaborating as the point of contact with outsourcing vendors,
investigators, and other external partners; overseeing country and
site validations, site selection, and recruitment; and responsible
for clients trial education to site.
- Collaborating internally with local PV, Regulatory, GMH/GHH to
align key decisions in countries and supporting local/regional
strategy development consistent with long-term corporate needs in
conjunction with CRD and Regional Operations. Requirements:
- Bachelor's degree in science or comparable
- Thorough knowledge of ICH Guidelines and GCP including a basic
understanding of regulatory requirements in other countries
- Thorough understanding of the drug development process
- Fluent in local office language and in English, both written
and verbal
- Minimum of 5-6 years in clinical research in which some
experience should be in a CRA capacity.
- Must have strong understanding of local regulatory environment,
country regulations, client policies and procedures, quality
standards.
- Strong scientific and clinical research knowledge is required
for this position.
- A strong understanding of clinical trial planning, management
and metrics is essential as well as the ability to focus on
multiple deliverables and protocols simultaneously.
- The role will require proven ability to collaborate and lead
high performing cross-functional teams also in a virtual
environment.
- The position requires strong leadership skills (scientific and
business) and ability to coordinate and lead local teams to high
performance.
- Good organizational and time management skills
- Working knowledge of ICH, FDA, local regulatory requirements,
IRB/IEC and other applicable regulations/guidelines; familiarity
with investigator start up documents; previous interaction with
operational project team and investigative sites preferred
- Excellent communication skills, oral and written
- Self-motivation with the ability to work under pressure to meet
deadlines
- Works well independently as well as in team environment
- tail and process oriented
- Positive attitude and approach
- Interact with internal and external customers with high degree
of professionalism and discretion
- Multi-tasking capability.
- Good computer skills with good working knowledge of a range of
computer packages
- Ability to lead and develop junior staff
- Flexible and adaptable to a developing work environment
Covid-19 Vaccination Required Pay Range: - - -129K - 165K Benefits:
All job offers will be---based on a candidate's skills and prior
relevant experience, applicable---degrees/certifications,---as well
as internal equity and market data.---Regular, full-time or
part-time employees working 20 or more hours per week are eligible
for comprehensive benefits including: Medical, Dental, Vision,
Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time
off (FTO), Company bonus where applicable. - For more detailed
information, please click here. - - - #LI - Remote Labcorp is proud
to be an Equal Opportunity Employer: As an EOE/AA employer, Labcorp
strives for diversity and inclusion in the workforce and does not
tolerate harassment or discrimination of any kind. We make
employment decisions based on the needs of our business and the
qualifications of the individual and do not discriminate based upon
race, religion, color, national origin, gender (including pregnancy
or other medical conditions/needs), family or parental status,
marital, civil union or domestic partnership status, sexual
orientation, gender identity, gender expression, personal
appearance, age, veteran status, disability, genetic information,
or any other legally protected characteristic. We encourage all to
apply. For more information about how we collect and store your
personal data, please see ourPrivacy Statement.
Keywords: Labcorp Drug Development, Labcorp, Durham , Clinical Research Manager, Healthcare , Durham, North Carolina
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