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:10.0pt">

• 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.

text-align:justify;text-indent:-.25in;mso-list:l7 level1 lfo9;tab-stops:list .5in">

• l8 level1 lfo1;tab-stops:list .5in">Ensure study start-up activities comply with ICH-GCP guidelines regulatory requirements and company SOPs.
• l8 level1 lfo1;tab-stops:list .5in">Develop and manage timelines ensuring study start-up activities are completed on time and within budget.
• tab-stops:list .5in">Responsible for the overall effective operation of protocols which involve the collaboration with clinical research administration departments and all central offices.
• tab-stops:list .5in">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.
• tab-stops:list .5in">Prepares for and attends clinical department meetings for assigned studies.
• l2 level1 lfo2;tab-stops:list .5in">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.
• l2 level1 lfo2;tab-stops:list .5in">Coordinate with external vendors and other departments to address any financial discrepancies or issues related to study budgets.
• l1 level1 lfo3;tab-stops:list .5in">Lead the development negotiation and execution of study-related contracts including site contracts investigator agreements and vendor agreements.
• l1 level1 lfo3;tab-stops:list .5in">Collaborate with legal procurement and other internal teams to ensure that contracts meet the company�s policies and regulatory requirements.
• l1 level1 lfo3;tab-stops:list .5in">Ensure the timely execution of contracts to allow for efficient site activation and study start-up.
• l1 level1 lfo3;tab-stops:list .5in">Address any issues or concerns raised during the contract negotiation process and resolve them promptly.
• l3 level1 lfo4;tab-stops:list .5in">Supervise a team of study start-up coordinators and assistants ensuring proper resource allocation and timely completion of tasks.
• l3 level1 lfo4;tab-stops:list .5in">Provide ongoing training coaching and mentorship to the study start-up team fostering an environment of continuous improvement.
• l3 level1 lfo4;tab-stops:list .5in">Evaluate team performance provide regular feedback and conduct performance appraisals.
• l4 level1 lfo5;tab-stops:list .5in">Ensure timely and accurate submission of regulatory documents to ethics committees regulatory authorities and other relevant bodies.
• l4 level1 lfo5;tab-stops:list .5in">Address any regulatory issues that arise during the start-up phase ensuring compliance with regulatory standards and guidelines.
• l4 level1 lfo5;tab-stops:list .5in">Stay current with local and international regulations including but not limited to ICH-GCP FDA EMA and other regional authorities.
• l6 level1 lfo6;tab-stops:list .5in">Identify and proactively resolve issues that may delay the study start-up process.
• l6 level1 lfo6;tab-stops:list .5in">Monitor and address any risks related to site activation contract negotiation or regulatory submission.
• l6 level1 lfo6;tab-stops:list .5in">Collaborate with cross-functional teams to implement solutions and mitigate potential risks.
• l5 level1 lfo7;tab-stops:list .5in">Serve as the primary point of contact for internal stakeholders and external partners regarding study start-up activities.
• l5 level1 lfo7;tab-stops:list .5in">Provide regular updates on study start-up progress timelines and milestones to department staff study PIs and senior management.
• l5 level1 lfo7;tab-stops:list .5in">Foster effective communication between clinical teams sites and stakeholders to ensure alignment and smooth transitions from start-up to full study execution.
• l0 level1 lfo8;tab-stops:list .5in">Analyze current processes and identify opportunities for efficiency improvements in study start-up activities.
• l0 level1 lfo8;tab-stops:list .5in">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:

mso-bidi-font-family:Symbol">� Bachelor�s degree in Life Sciences Nursing Pharmacy

or a related field (advanced degree preferred).

mso-bidi-font-family:Symbol">� Strong understanding of clinical trial processes

regulations and industry standards (e.g. ICH-GCP FDA EMA).

mso-bidi-font-family:Symbol">� Experience with study start-up activities including

regulatory submissions site identification feasibility assessments and

contract negotiation.

mso-bidi-font-family:Symbol">� Strong background in contract negotiation and

execution particularly in clinical trial settings.

mso-bidi-font-family:Symbol">� Exceptional mentoring and team management skills.

mso-bidi-font-family:Symbol">� Excellent organizational project management and

communication skills.

mso-bidi-font-family:Symbol">� Ability to manage multiple priorities and projects in

a fast-paced environment.

mso-bidi-font-family:Symbol">� Proficient in using clinical trial management systems

(CTMS) and other clinical trial-related software.

mso-bidi-font-family:Symbol">� Prior experience with study start-up either within an

institutional department in a CRO or sponsor setting.

mso-bidi-font-family:Symbol">� This role may require occasional travel to clinical

sites conferences or company meetings.

mso-bidi-font-family:Symbol">� Ability to work in an office or remote setting.

mso-fareast-font-family:Symbol;mso-bidi-font-family:Symbol">�

10.0pt">Strong problem-solving skills

mso-fareast-font-family:Symbol;mso-bidi-font-family:Symbol">�

10.0pt">Detail-oriented

mso-bidi-font-family:Symbol">� Proficiency in Microsoft Office (Excel Power Point

Outlook and Word).

mso-bidi-font-family:Symbol">� Highly effective verbal and writing skills required.

mso-fareast-font-family:Symbol;mso-bidi-font-family:Symbol">�

10.0pt">Ability to foster smooth communications and teamwork among clinical

research faculty fellows and staff as well as external organizations necessary

mso-fareast-font-family:Symbol;mso-bidi-font-family:Symbol">�

10.0pt">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