Clinical Trial Manager/Senior Clinical Trial Manager (Multiple Locations)
Company: Loxo Oncology, Inc.
Location: South San Francisco
Posted on: June 7, 2021
Loxo Oncology at Lilly conducts discovery research, clinical
development and regulatory affairs for oncology, with the goal of
creating a pipeline of therapies that have the potential to make a
meaningful difference for patients. Loxo Oncology at Lilly was
created in December 2019, combining the Lilly Research Laboratories
oncology organization and Loxo Oncology, which was acquired by
Lilly in early 2019. The unit has team members in Boulder, CO,
Indianapolis, IN, New York City, NY, South San Francisco, CA, San
Diego, CA, Stamford, CT, and Madrid, Spain.
The Clinical Trial Manager / Senior Clinical Trial Manager will
manage one (or more) clinical studies including leading the
planning, organization, and coordination of all operational aspects
of the clinical study from protocol development through database
lock / study closure; ensure delivery on time, within budget, and
of high quality in compliance with ICH/GCP, Regulatory Authorities'
regulations/guidelines, and applicable SOPs/WPs; Provide
operational leadership on cross-functional study team(s) and
performance and quality oversight of Contract Research Organization
(CRO) teams and other vendors.
Roles and Responsibilities of the Position
- Provide operational leadership on development, management and
maintenance of study deliverables [i.e. timelines, study plans,
documents, etc.] through collaboration with internal and external
- Lead and manage the execution of clinical trials, drive to
solutions across a multi-functional study team.
- Anticipate and resolve complex and key technical, operational
or business problems with multi-functional study team; evaluate and
determine issues that require escalation.
- Use performance metrics and quality indicators to drive study
- Support Health Authority inspections and CQA audits as
required, including driving inspection/audit readiness through life
- Manage study team and/or CRO to ensure completeness & accuracy
of the required data in study management tools including clinical
trial management systems, patient enrollment forecasting, etc.
- Proactively identify potential risks and lead the
development/implementation of actions to avoid or mitigate;
identify points for escalation.
- Develop and maintain collaborative relationships with internal
and external partners/stakeholders including both vendors and
- Collaborate with vendors and other study team members regarding
study specific issues; drive team through issue resolution.
- Lead and/or collaborate in the creation and review of study
documents, including but not limited to the Protocol, Informed
Consent Form (ICF) and other patient facing materials, case report
forms, and clinical study reports. Manage completion of these
deliverables to ensure timelines are upheld. Ensure study documents
are updated as needed throughout the trial.
- Partner with internal contracts management to ensure review,
finalization, and escalation as needed of site contracts and
- Plan site and country identification and selection in
collaboration with internal partners.
- As appropriate per vendor/scope of work, manage and/or
participate in vendor selection, specification development and
- Ensure management of the TMF set-up, ongoing quality review,
and final reconciliation.
- Liaise as needed with CRO and investigative sites to ensure
clinical trial data is captured and resolved as required.
- Contribute to data review/cleaning of clinical data as needed
and as defined by study plans.
- Lead study meetings including presenting as a subject matter
expert as needed, ensuring agenda and meeting minutes are generated
and distributed as needed.
- Manage the development/coordination of study training and study
training materials for study team, investigational sites, and
- Contribute to oversight of the required country regulatory
(e.g. CTA, MoH) and country/site IRB/IEC
- Ensure the collection of various study documents such as
country/site insurance, CSR appendices, etc. is completed as
- Manage Investigator Meeting coordination and planning.
- Lead and assist in training other Clinical Operations roles
- In addition to all activities listed, Senior Clinical Trial
Managers must be able to manage large, complex trials and/or manage
multiple ongoing studies simultaneously with minimal
Required Qualifications and Background
- BA/BS degree in a relevant discipline with 5+ years' experience
in clinical drug development required at Clinical Trial Manager
level; 6+ years' experience required for Senior Clinical Trial
- For oncology studies: Oncology and/or Hematology experience
preferred; for clinical pharmacology studies: Clinical
Pharmacology/Healthy Volunteer experience preferred
- Experience in managing global clinical trials preferred.
- Experience with managing clinical research budgets.
- Knowledge of ICH/GCP and regulatory guidelines/directives.
- Experience with managing a multi-functional team, including
leadership skills and driving deliverables.
- Demonstrates analytical approach and anticipation of
- Identifies gaps and provides constructive feedback and
- Follows issues to resolution and escalates as appropriate.
- Ability to multi-task effectively and prioritize assignments
from multiple sources.
- Excellent organizational skills.
- Strong communication skills, both written and oral; proficiency
- Strong knowledge of MS applications including (but not limited
to) MS Project, Word, Excel, PowerPoint.
- Knowledge of study tools including electronic system skills
such as CTMS/ EDC/ IRT/ eTMF.
- Knowledge of drug development process. Proactively shares
information, ideas, input, and/or expertise with team members.
Demonstrates concern for high quality outcomes.
- Responds flexibly to changing business demands and
opportunities, proactively looking for ways to contribute.
Available locations for this role:
- Stamford, CT
- South San Francisco, CA
- US Based-Remote
Physical Demands/ Travel:
The physical demands of this job are consistent with light
office duties. Up to 15% travel may be required.
The physical demands here are representative of those that must
be met by an employee to successfully perform the essential
functions of this job.
This position's work environment is in an office.
The work environment characteristics described here are
representative of those an employee encounters while performing the
essential functions of this job.
Loxo Oncology, Inc. (Loxo) currently anticipates that the base
salary for this position could range from between $103,200 to
$151,423 for a Clinical Trial Manager and $118,700 to $174,137 for
a Sr. Clinical Trial Manger and will depend, in part, on the
successful candidate's qualifications for the role, including
education and experience. This position also will be eligible for a
company bonus(depending, in part, on company and individual
performance). In addition, Loxo provides a comprehensive benefit
program to eligible employees, including vacation, medical, dental
and vision benefits; participation in a 401(k) plan; life and
accidental death and disability coverage; parental leave benefits
and employee discounts for certain items. The compensation
described above is subject to change and could be higher or lower
than the range described above. Further, Loxo reserves the right to
amend, modify, or terminate its compensation and benefit programs
in its sole discretion.
- To perform this job successfully, an individual must be able to
perform the role and responsibilities satisfactorily. The
requirements listed above are representative of the knowledge,
skill, and/or ability required. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and
does not discriminate on the basis of age, race, color, religion,
gender, sexual orientation, gender identity, gender expression,
national origin, protected veteran status, disability or any other
legally protected status.
Keywords: Loxo Oncology, Inc., South San Francisco , Clinical Trial Manager/Senior Clinical Trial Manager (Multiple Locations), Other , South San Francisco, California
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