Clinical Research Project Manager -Oncology ( Home-Based - USA )
Company: Covance
Location: Boston
Posted on: January 15, 2021
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Job Description:
Job Overview:Clinical Research Manager -OncologyHome-Based in
the USA Why settle for one thing when you can have everything?
Covance gives you the best two-for-one opportunity for career
growth. Who doesn---t want twice the perks? Working at
Covance---one of the largest FSP CROs---and partnering with one
sponsor with a dedicated therapeutic focus. You can have it allAs a
Covance employee dedicated to an FSP project, you will bring your
specialized discipline to a core team working directly with one
sponsor. Whether your specialization is in clinical monitoring,
clinical project management, data management, biometrics or
pharmacovigilance, Covance has an FSP opportunity to match your
area of expertise. You will enjoy the best of both worlds---all the
benefits that come along with Covance---s Energizing Purpose,
Exceptional People and Extraordinary Potential combined with
working exclusively with one sponsor and this also comes with the
benefit of bringing your strong therapeutic experience to allow
your expertise to shine through.Covance---s FSP model is flexible
and scalable. Our teams are collaborative and proactive --- a great
place for you to continue honing your therapeutic skills and
growing and excelling in new and exciting research.Covance---s
reach is global --- extending to 60 countries making us one of the
largest FSP CROs. No matter where you are located on the globe, we
have an FSP opportunity for you.The Clinical Research Manager is
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 countriesMaking 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
skillsOverseeing country commitments, compliance and training
needs. Additionally, business leadership and alignment with
corporate requires that individual has ability to lead across
several dimensions simultaneouslyWorking 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 organizationBuilding and maintaining
relationships with investigators and other external partners and
promote Client---s reputationRepresenting Client in Pharma industry
issues and in seeking influence in external R&D environment, in
collaboration with CRDAccountable for performance and compliance
with assigned protocols in relation to ICH/GCP and country
regulations along with client policies, procedures and adverse
event reporting requirementsProactively driving/tracking execution
and performance of deliverables/timelines/results to meet country
commitments; collaborating with local clinical operations roles;
and forecasting country needsOverseeing 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 clientCollaborating 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.Education/Qualifications:Minimum Required:Bachelor---s
degree in science or comparable Thorough knowledge of ICH
Guidelines and GCP including a basic understanding of regulatory
requirements in other countriesThorough understanding of the drug
development processFluent in local office language and in English,
both written and verbalExperience:Minimum Required:Minimum of 5-6
years in clinical research in which some experience should be in a
CRA capacity.1 years of experience as a PM or CTL managing oncology
projectsMust 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
skillsWorking 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 preferredExcellent
communication skills, oral and writtenSelf-motivation with the
ability to work under pressure to meet deadlinesWorks well
independently as well as in team environmenttail and process
orientedPositive attitude and approachInteract with internal and
external customers with high degree of professionalism and
discretionMulti-tasking capability.Good computer skills with good
working knowledge of a range of computer packagesAbility to lead
and develop junior staff Flexible and adaptable to a developing
work environmentTravel Requirements: --- 20-40 % travel may be
required. International and Domestic Travel may be required,
including overnight stays as necessary consistent with project
needs and office location (this will vary based on country and
project needsJob SummaryJob number: 56304Date posted :
2020-12-09Profession: ClinicalEmployment type: Full Time
Keywords: Covance, Boston , Clinical Research Project Manager -Oncology ( Home-Based - USA ), Healthcare , Boston, Massachusetts
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