Study Start up Clinical Trial - Program Manager

Summary:

Reporting to the Regulatory
& Quality Manager of the Brown University Health Office of Cancer Research
and in collaboration with the department Director the Study Start-Up Clinical
Trial Program Manager will lead and oversee the initiation and execution of
clinical trials in the Office of Cancer Research ensuring that all start-up activities
are conducted in compliance with regulatory requirements company policies and
standard operating procedures (SOPs).

They will oversee the
activation process from start to finish (open to accrual status) which
involves interactions with sponsors Contract Research Organizations (CROs)
External Vendors Institutional Review Boards (IRBs) and internal staff and
institutional external departments. This process is performed in collaboration
with the Principal Investigator study team members and other relevant
personnel. They will act as a liaison between different central departments and
research teams throughout the activation lifecycle of the clinical study. Maintains
real-time tracking of the progress and milestones of assigned trials and
proactively alerts to potential delays. Responsible for confirming all
institutional requirements are met prior to activation/implementation.

This role will lead the study
start-up process from site/PI identification through to site activation and
overall readiness for trial execution. As a program manager with supervisory
responsibilities this position will also mentor train and educate and
supervise a team of department study start-up coordinators and assistants
ensuring alignment with department goals and organizational priorities.

This role is also responsible
for implementing quality control measures evaluating and enhancing processes
and systems and collecting and reporting data to internal and external
stakeholders. This role will also be responsible for overseeing the development
of study budgets and contracts in collaboration with cross-functional teams.

Responsibilities:

PRINCIPAL DUTIES AND
RESPONSIBILITIES:

* Oversee and lead start-up activities of clinical
trials including study site identification selection feasibility
assessments SRMC submission and outcome contracts budget IRB submission and
regulatory document preparation.

• Ensure
  study start-up activities comply with ICH-GCP guidelines regulatory
  requirements and company SOPs.
• Develop
  and manage timelines ensuring study start-up activities are completed on
  time and within budget.
• Responsible for the
  overall effective operation of protocols which involve the collaboration
  with clinical research administration departments and all central
  offices.
• Serves as a liaison
  between central offices and research staff during the life cycle of a
  protocol to navigate protocols through the clinical research systems.
• Prepares for and
  attends clinical department meetings for assigned studies.

• Collaborate
  with cross-functional teams including external contractors to ensure
  that the development of comprehensive study budgets is in alignment with
  overall project goals and timelines.
• Coordinate
  with external vendors and other departments to address any financial
  discrepancies or issues related to study budgets.

• Lead
  the development negotiation and execution of study-related contracts
  including site contracts investigator agreements and vendor agreements.
• Collaborate
  with legal procurement and other internal teams to ensure that contracts
  meet the company*s policies and regulatory requirements.
• Ensure
  the timely execution of contracts to allow for efficient site activation
  and study start-up.
• Address
  any issues or concerns raised during the contract negotiation process and
  resolve them promptly.

• Supervise
  a team of study start-up coordinators and assistants ensuring proper
  resource allocation and timely completion of tasks.
• Provide
  ongoing training coaching and mentorship to the study start-up team
  fostering an environment of continuous improvement.
• Evaluate
  team performance provide regular feedback and conduct performance
  appraisals.

• Ensure
  timely and accurate submission of regulatory documents to ethics
  committees regulatory authorities and other relevant bodies.
• Address
  any regulatory issues that arise during the start-up phase ensuring
  compliance with regulatory standards and guidelines.
• Stay
  current with local and international regulations including but not
  limited to ICH-GCP FDA EMA and other regional authorities.

• Identify
  and proactively resolve issues that may delay the study start-up process.
• Monitor
  and address any risks related to site activation contract negotiation or
  regulatory submission.
• Collaborate
  with cross-functional teams to implement solutions and mitigate potential
  risks.

• Serve
  as the primary point of contact for internal stakeholders and external
  partners regarding study start-up activities.
• Provide
  regular updates on study start-up progress timelines and milestones to department
  staff study PIs and senior management.
• Foster
  effective communication between clinical teams sites and stakeholders to
  ensure alignment and smooth transitions from start-up to full study
  execution.

• Analyze
  current processes and identify opportunities for efficiency improvements
  in study start-up activities.
• Collaborate
  with leadership to implement process changes and improvements to optimize
  the study start-up timeline.

Performs
other related duties as necessary.

Other information:

BASIC KNOWLEDGE:

* Bachelor*s degree in Life Sciences Nursing Pharmacy
or a related field (advanced degree preferred).

* Strong understanding of clinical trial processes
regulations and industry standards (e.g. ICH-GCP FDA EMA).

* Experience with study start-up activities including
regulatory submissions site identification feasibility assessments and
contract negotiation.

* Strong background in contract negotiation and
execution particularly in clinical trial settings.

* Exceptional mentoring and team management skills.

* Excellent organizational project management and
communication skills.

* Ability to manage multiple priorities and projects in
a fast-paced environment.

* Proficient in using clinical trial management systems
(CTMS) and other clinical trial-related software.

* Prior experience with study start-up either within an
institutional department in a CRO or sponsor setting.

* This role may require occasional travel to clinical
sites conferences or company meetings.

* Ability to work in an office or remote setting.

* Strong problem-solving skills

* Detail-oriented

* Proficiency in Microsoft Office (Excel Power Point
Outlook and Word).

* Highly effective verbal and writing skills required.

* Ability to foster smooth communications and teamwork among clinical
research faculty fellows and staff as well as external organizations necessary

* SoCRA (Society of Clinical Research Associates) certified or eligible
within 18 months of hire

EXPERIENCE:

Minimum of 5 years of
experience in clinical research with at least 1 year supervisory role.

INDEPENDENT ACTION:

Performs independently within
the department policies and practices.

SUPERVISORY RESPONSIBILITY:

Up to 10 FTEs.

Brown University Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status. Brown University Health is a VEVRAA Federal Contractor.

Location: Rhode Island Hospital USA:RI:Providence

Work Type: Full Time

Shift: Shift 1

Union: Non-Union