Program Manager - Multicenter Surgical Trial Program - MD Anderson
Houston, TX
About the Job
JOB SPECIFIC COMPETENCIES
Programmatic and Publication Support
· Develop program plans, timelines, and deliverables in collaboration with lead investigator and team. Lead daily operations, planning, and coordination activities for the Gyn Onc Multicenter Surgical Trial Program.
· Create and secure stakeholder buy-in for project timelines, key deliverables, milestones, and long and short-term goals. Oversee quality control and data management procedures, including the development and maintenance of project databases.
· Under the supervision of the protocol primary investigator (PI) or supervisor, assume responsibility for the overall effective operation and conduct of designated protocols.
· Provide technical assistance and guidance on project deliverables to key collaborators as needed. Initiate and maintain effective relationships with key faculty, senior leadership, and strategic partners relevant to the execution and advancement of the core program portfolio.
· Contribute to the effective design, planning, coordination, and documentation of all Gyn Onc Multicenter Surgical Trial Program projects and the overall program. Lead implementation and conduct of LANCE trial and designated study protocols.
· Support PI in data evaluation and analysis for publications. Collaborate with statisticians to prepare data for analysis. Compile protocol data for manuscript development; write and edit manuscripts and related materials.
· Demonstrate strong organizational skills and the ability to work effectively with cross-functional teams.
· Exhibit excellent oral and written communication skills when contacting patients, physicians, collaborators, and other institutions and agencies. Assimilate pertinent information to compose written correspondence.
· Mentor and train research team members or other support staff as needed. Develop a process to monitor new research staff training and confirm comprehension of key functions.
· Attend departmental or institutional research meetings.
Clinical Trial Initiation & Multi-Center Coordination
· Under supervision of the protocol primary investigator (PI) or manager, assume responsibility for the overall effective operation and conduct of designated protocols.
· Lead and organize monthly study team meetings and bimonthly PI meetings for multicenter trials. Prepare all related materials and generate reports for discussion, including meeting agendas, enrollment and/or data updates.
· Participate in protocol site initiation/logistics meetings. Assist in preparing protocol-specific training materials as needed.
· Collaborate with PI and protocol administration team to collect and develop critical information for protocol submission and revisions. Develop research documents and tools to aid in meeting clinical trial requirements.
· Support principal investigators and study teams in evaluating potential sub-sites for participation in multicenter clinical trials.
· Develop and maintain relationships with participating sub-site investigators and study teams for multicenter trials, ensuring effective communication and collaboration to implement the study as designed and within approved timelines.
· Provide protocol database training for all sites in multicenter studies. Respond in a timely manner to data-related questions from sites.
· Schedule monitoring visits with study sites and track all scheduled monitor appointments; Review and monitor all data entered by external sites; issue queries and work with sites until resolution.
· Ensure all clinical trial sites comply with the study protocol and good clinical practice (GCP) guidelines. Adhere to policies and procedures related to clinical trial conduct.
Direct Support for Patient Management & Data Management
· Act as a liaison with patients, physicians, and other research staff in providing administrative and patient care services for assigned research protocols.
· Assess patients and verify protocol eligibility through personal interviews and/or medical record review. Participate in the informed consent process and ensure it is understood, signed, and processed appropriately.
· Register protocol patients into and maintain patient status in OnCORe per Standard Operating Procedure (SOP) and institutional standard practice. Randomize patients through the Institutional CTC website and communicate results with providers.
· Develop and maintain patient tracking systems. Provide feedback to physicians and
· multidisciplinary teams regarding required screening and on-study activities.
· Document study-related data in patient medical records, protocol-specific documents, and institutional reports as required. Collaborate with healthcare providers and research staff to document patient care.
· Maintain knowledge of adverse events and surgical complications. Submit adverse event information to PI, study sponsors, and/or the institutional IND office per protocol.
· Participate in maintaining data and activities for industry, institutional, and federal clinical trial audits.
· Assist in developing and maintaining a system or database for collecting and organizing protocol data. Abstract patient data from electronic health records and relevant source documents and enter research study data into electronic case report forms (CRFs) or local data systems in accordance with protocol requirements and departmental timelines.
· Address data entry omissions or inconsistencies and communicate revision requests to clinical staff for correction.
· Prepare and review necessary data for monitoring visits, audits, and safety summaries. Generate protocol summary reports and user-generated data reports as requested.
Required Education:
Bachelor's degree.
Preferred Education:
Master's degree.
Required Experience:
Five years related experience to include three years program management experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience.
Preferred Experience:
Surgical trials experience, regulatory knowledge, REDCap experience, background in biomedical science, experience working on a medium size team.
Work Schedule:
This is a hybrid position.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
#LI-Hybrid
Programmatic and Publication Support
· Develop program plans, timelines, and deliverables in collaboration with lead investigator and team. Lead daily operations, planning, and coordination activities for the Gyn Onc Multicenter Surgical Trial Program.
· Create and secure stakeholder buy-in for project timelines, key deliverables, milestones, and long and short-term goals. Oversee quality control and data management procedures, including the development and maintenance of project databases.
· Under the supervision of the protocol primary investigator (PI) or supervisor, assume responsibility for the overall effective operation and conduct of designated protocols.
· Provide technical assistance and guidance on project deliverables to key collaborators as needed. Initiate and maintain effective relationships with key faculty, senior leadership, and strategic partners relevant to the execution and advancement of the core program portfolio.
· Contribute to the effective design, planning, coordination, and documentation of all Gyn Onc Multicenter Surgical Trial Program projects and the overall program. Lead implementation and conduct of LANCE trial and designated study protocols.
· Support PI in data evaluation and analysis for publications. Collaborate with statisticians to prepare data for analysis. Compile protocol data for manuscript development; write and edit manuscripts and related materials.
· Demonstrate strong organizational skills and the ability to work effectively with cross-functional teams.
· Exhibit excellent oral and written communication skills when contacting patients, physicians, collaborators, and other institutions and agencies. Assimilate pertinent information to compose written correspondence.
· Mentor and train research team members or other support staff as needed. Develop a process to monitor new research staff training and confirm comprehension of key functions.
· Attend departmental or institutional research meetings.
Clinical Trial Initiation & Multi-Center Coordination
· Under supervision of the protocol primary investigator (PI) or manager, assume responsibility for the overall effective operation and conduct of designated protocols.
· Lead and organize monthly study team meetings and bimonthly PI meetings for multicenter trials. Prepare all related materials and generate reports for discussion, including meeting agendas, enrollment and/or data updates.
· Participate in protocol site initiation/logistics meetings. Assist in preparing protocol-specific training materials as needed.
· Collaborate with PI and protocol administration team to collect and develop critical information for protocol submission and revisions. Develop research documents and tools to aid in meeting clinical trial requirements.
· Support principal investigators and study teams in evaluating potential sub-sites for participation in multicenter clinical trials.
· Develop and maintain relationships with participating sub-site investigators and study teams for multicenter trials, ensuring effective communication and collaboration to implement the study as designed and within approved timelines.
· Provide protocol database training for all sites in multicenter studies. Respond in a timely manner to data-related questions from sites.
· Schedule monitoring visits with study sites and track all scheduled monitor appointments; Review and monitor all data entered by external sites; issue queries and work with sites until resolution.
· Ensure all clinical trial sites comply with the study protocol and good clinical practice (GCP) guidelines. Adhere to policies and procedures related to clinical trial conduct.
Direct Support for Patient Management & Data Management
· Act as a liaison with patients, physicians, and other research staff in providing administrative and patient care services for assigned research protocols.
· Assess patients and verify protocol eligibility through personal interviews and/or medical record review. Participate in the informed consent process and ensure it is understood, signed, and processed appropriately.
· Register protocol patients into and maintain patient status in OnCORe per Standard Operating Procedure (SOP) and institutional standard practice. Randomize patients through the Institutional CTC website and communicate results with providers.
· Develop and maintain patient tracking systems. Provide feedback to physicians and
· multidisciplinary teams regarding required screening and on-study activities.
· Document study-related data in patient medical records, protocol-specific documents, and institutional reports as required. Collaborate with healthcare providers and research staff to document patient care.
· Maintain knowledge of adverse events and surgical complications. Submit adverse event information to PI, study sponsors, and/or the institutional IND office per protocol.
· Participate in maintaining data and activities for industry, institutional, and federal clinical trial audits.
· Assist in developing and maintaining a system or database for collecting and organizing protocol data. Abstract patient data from electronic health records and relevant source documents and enter research study data into electronic case report forms (CRFs) or local data systems in accordance with protocol requirements and departmental timelines.
· Address data entry omissions or inconsistencies and communicate revision requests to clinical staff for correction.
· Prepare and review necessary data for monitoring visits, audits, and safety summaries. Generate protocol summary reports and user-generated data reports as requested.
Required Education:
Bachelor's degree.
Preferred Education:
Master's degree.
Required Experience:
Five years related experience to include three years program management experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience.
Preferred Experience:
Surgical trials experience, regulatory knowledge, REDCap experience, background in biomedical science, experience working on a medium size team.
Work Schedule:
This is a hybrid position.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
- Requisition ID: 167192
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 77,000
- Midpoint Salary: US Dollar (USD) 96,000
- Maximum Salary : US Dollar (USD) 115,000
- FLSA: exempt and not eligible for overtime pay
- Fund Type: Soft
- Work Location: Hybrid Onsite/Remote
- Pivotal Position: No
- Referral Bonus Available?: No
- Relocation Assistance Available?: No
- Science Jobs: No
#LI-Hybrid
Source : MD Anderson