Associate Director, Clinical Operations
Company: GoRecruitMe
Location: Cambridge
Posted on: March 18, 2023
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Job Description:
Role: Associate Director, Clinical Operations We are looking for
a energetic and passionate Associate Director, Clinical Operations
who is excited to plan and lead timely and high quality oncology
clinical trial execution. The ideal candidate has a track record of
executing complex, on-time clinical trials at a biotech/pharma
company and has begun working beyond study management and into
program management. The AD leads activities to oversee the conduct
of clinical research at our Company in accordance with FDA, EMA,
GCP, and ICH guidelines. This role will be responsible for
collaborative oversight of cross-functional study team activities,
as well as exceptional management of and partnership with external
vendors and stakeholders (e.g., CROs, central labs, IRBs/ECs, and
other external partners). Who are we looking for? - You have been
working effectively in an independent trial management role for at
least 3 years and are looking for an invigorating role where you
can work autonomously on a high profile company program to execute
study deliverables with quality. - You are an energetic and
passionate Clinical Operations professional who likes to think
outside of the box, proactively seeks out and recommends process
improvements and is passionate about the company's mission of
discovering and developing new medications - You are a resourceful
self-starter and team player with a strong results orientation -
You are open and authentic and can develop trusting relationships
to move projects forward despite challenges. - You act like an
owner and take accountability; you are reliable - You are
resourceful and apply critical thinking to solve problems and add
value to the Clinical Development team - You have strong written
and verbal communication and know how to seek clarity in ambiguous
situations What are we looking for? - A driven professional who is
comfortable supporting the development of procedures in parallel
with doing the work - A collegial team player who enjoys working in
close collaboration with external vendors and teams; someone who
understands the criticality of vendor partnerships for the
execution of clinical trial conduct - A person who thrives in a
small company atmosphere and is willing to "roll up their sleeves"
to support all aspects of clinical trial execution (some CTA tasks
through program management) - A person who acts with a sense of
urgency and a quality-mindset What are we offering? - Membership
within a growing, supportive, highly connected and collegial
organization - Being part of passionate, involved, fun! and
cutting-edge Clinical Development Team - the ability to wear
multiple hats and gain exposure to many aspects of the business -
Ability to develop within Clinical Development Operations under
strong mentorship; future potential opportunity to be a line
manager and develop a team - Exposure to pioneering science and the
discovery of drugs to help treat patients with cancer What you will
do: - Leads the activities of the protocol level team as it relates
to study-level strategy, timelines, goals, and quality; Liaises
with cross functional team members for coordination of clinical
study support to include but not limited to drug supply management,
quality management, regulatory management initiatives -
Participates on the molecule Program Team - Evaluates, selects and
ensures appropriate oversight of Contract Research Organizations
(CROs) and other external vendors. Builds solid relationships with
key counterparts at CRO(s) and other external vendors; participates
in CRO Governance, where applicable - Coordinates the development
and distribution of critical study documents, including Informed
Consent Forms, operational documents, study reference documents,
site materials, trainings and other study related documents;
supports the development of clinical study protocols, clinical
study reports and other documents as needed - Communicates with
clinical trial sites as appropriate to ensure optimal Sponsor-Site
relationships - Drives site start-up, subject enrollment, clinical
monitoring, site and vendor compliance activities and data metrics
from CROs and other external vendors. - Communicates trial status
within and outside the study team to ensure cross-functional
alignment of expectations, priorities, and deliverables - Develops
and manages the study-level budget(s) and demonstrates
accountability for the management of the budget through
facilitation of WOs, CNFs and change orders according to study
needs and tracking vendor performance against scopes of work,
contracts, and invoices; manages budget forecasting and accruals in
collaboration with Company FP&A. - Analyzes clinical study and
investigative site risks and implements corrective actions, where
required - Provides oversight of the applicable study drug(s)
including supply projections, and partners with the Clinical Supply
Chain for study drug distribution, labeling and destruction -
Performs quality assurance checks (e.g. reviewing protocols for
operational effectiveness, monitoring trip reports for potential
gaps in site/CRA training, conducting co-monitoring visits at
clinical sites, reviewing data listings at interim analysis
milestones) - Supports and collaborates with GCP QA during
site/study audit and vendor selection/auditing activities - Leads
Clinical Operations preparation of inspection readiness activities
for FDA and other applicable regulatory body audits and/or meetings
- Owns the Trial Master File for assigned trials; ensures
appropriate quality oversight and QC of required elements of TMF -
Maintains internal document repositories (e.g. Sharepoint) -
Assists with identifying and implementing best practices and
continuous improvement plans within the company - Participation in
SOP, work instruction, and/or template development and review, as
required - Performs administrative functions and additional duties
as assigned and appropriate What you will bring: - A deep
understanding of Clinical Operations and trial management - A
willingness to learn new things, adapt to new ways and go with the
flow - An ability to determine priority and risk associated with
study and program decisions - A positive, can-do attitude and a
team mindset - An interest in your own personal development Our
values: Transparency: We work with honesty, openness, and
integrity. Community : We collaborate and thrive together.
Patient-Focused : We are committed to finding new medicines for
patients. Resolve : We never give up on our mission. When You Join
Us You Will Have: One day a week in office --- Location reachable
by public transportation (Red Line) --- Customized and competitive
health coverage, including medical offered through BCBS (HMO/PPO),
dental, and vision --- Health Savings Account for medical expenses
--- Eligible from the first day for 401K with 100% match of the
first 5% --- A robust package of Company-paid insurance coverage,
including life insurance, short-term and long-term disability ---
Unlimited time off and 11 Holidays --- Winter Break: Company is
closed for a Winter Break between Christmas and New Year
Keywords: GoRecruitMe, Cambridge , Associate Director, Clinical Operations, Healthcare , Cambridge, Massachusetts
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