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Job Details

Senior Manager Global Clinical Development Operations Early Development Trial Leader Oncology

Company name
Johnson & Johnson Services, Inc.

Location
Spring House, PA

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Profile

JanssenResearch and Development, L.L.C., a member of Johnson and Johnson's Family of
Companies, is recruiting for a Senior Manager, Global Clinical Development
Operations (GCDO) Trial Leader, Oncology (GTL) located in Spring
House, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium; High Wycombe, UK; Leiden,
South Holland; or Breda, Netherlands.
At the Janssen Pharmaceutical
Companies of Johnson & Johnson, what matters most is helping people live
full and healthy lives. We focus on treating, curing and preventing some of the
most devastating and complex diseases of our time. And we pursue the most
promising science, wherever it might be found. We discover and develop innovative
medical solutions to address important unmet medical needs in oncology,
immunology, neuroscience, infectious diseases and vaccines, and cardiovascular
and metabolic diseases. We are Janssen. Our mission drives
us. Our patients inspire us. We collaborate with the world for the health of
everyone in it. Bring your talents to our mission, visit
http:\/\/www.janssenrnd.com\/ to learn more. Thriving
on a diverse company culture, celebrating the uniqueness of our employees and
committed to inclusion. Proud to be an equal opportunity employer. The Global
Clinical Development Operations (GCDO) Trial Leader, Oncology (GTL) has primary
global accountability at the trial level within the GCDO organization. The GTL
is accountable and provides operational expertise for the successful
cross-functional delivery of assigned early development clinical trial(s),
within agreed timelines and budget, and in alignment with all the applicable
SOPs and regulatory requirements. Principal
Responsibilities: Accountable
for oversight of external service providers (ESP), including ESP contracts and
budgets. In addition, he\/she will be involved in planning and execution of both
internally managed and outsourced trials, with scope from draft protocol
elements document to availability of the Clinical Study Report and applicable
disclosure of the trial results.The
GTL is responsible for leading the cross-functional Trial Team (including GCDO
and non-GCDO members) and collaborates with all trial team members, building
the trial operational plan, in alignment with the organizational and the
Therapeutic Area (TA) Clinical Team\u2019s objectives. The GTL defines risk
mitigation strategies and ensures implementation thereof.The
GTL maintains oversight of the trial by taking an operational leadership role
in a matrix organization; this includes coordinating activities in the Trial
Team and ensuring ad-hoc trial Working Groups are organized as needed, driving
issue identification and resolution, contingency planning, and decision-making.Identifies
risks and ensures mitigation and contingencies are being initiated and followed
through (including management of Corrective and Preventive Action Plans).Overall
trial budget and contract management, including updates for scope changes,
review & approval of external service provider (ESP) contracts, change
orders and ensures services are delivered.Drive
the final study placement, and ensure alignment with and communication to the
involved partners, including TA and regional GCO TA experts.Develop
the trial ESP strategy for the assigned trial in line with the overall program
ESP strategy. Responsible
for CRO management, including initiation of selection process, SOW development,
budget and change orders and oversight of all deliverables outsourced to the
CRO.Builds
and updates study-specific documents such as Monitoring Guidelines, Informed
Consent Form, IMP related documentation, Blinding Plan, country and site
feasibility related documents, Safety related documents, Protocol Deviations
and Issue processes, External Service Provider Oversight Plan, Filing and
Archiving Plan.Participates
in preparation for, Health Authority inspections and internal QA audits.Accountable
to drive lessons learned initiatives at trial level during and after trial
achievement completion; accountable for developing subsequent issue resolution
and process improvements as required.Strong
interaction with the Therapeutic Area, other GCDO functions, Biomarker groups,
Clinical Pharmacology, Clinical Supply Chain, Bioresearch Quality and
Compliance Group, Clinical Business Operations, Finance, Project Management
Organization, Regulatory and external partners to influence alignment on issues
and decisions affecting trial management, enabling successful trial outcome. QualificationsBachelor
of Science or University equivalent is required; preferably in Life Sciences
(e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)Minimum
of 8 years of clinical trial experience in the pharmaceutical industry or CRO
is required Strong
knowledge in Early Development clinical trials is highly preferredAn
exploratory scientific mindset with focus on disease area and PK\/PD\/biomarkers
is recommendedRelevant
experience in the Early Development of one of more of Janssen\u2019s Therapeutic
Areas and\/or healthy volunteer studies is preferredAbility
to lead all aspects of execution of a clinical trial and you demonstrate expertise
in vendor management is required Excellent
people leadership skills in a global, matrix environment is required; people
management experience is strongly preferredWillingness
and ability to travel up to 20% of the time, defined by business needs is
required

Company info

Johnson & Johnson Services, Inc.
Website : http://www.jnj.com

Company Profile
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Johnson & Johnson was founded more than 120 years ago. Since then, we’ve brought the world new ideas and products that have transformed human health and well-being.

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