Senior Manager, Clinical Data Management

Celcuity•Minneapolis, MN

1d•$175,000 - $192,000•Remote

About The Position

We are seeking a Senior Manager, Clinical Data Management who will report into the Executive Director, Clinical Data Management. You will focus on all aspects of the CDM process from project planning, the development of project documentation, system set-up, UAT through database lock. This person is a department-level contributor and may have oversight of junior CDM staff. The core duties and responsibilities of the Senior Manager, Clinical Data Management are delineated below. Responsibilities: Department Level: Responsible for timelines and quality of CDM deliverables for the assigned studies. Contributes to technical infrastructure of CDM such as not but limited to development of SOPs, departmental process improvement etc. Provides feedback and task assignment to meet department and company objectives. Supports budget and resource planning across assigned projects as required. Participates in CRO/vendor selection process for outsourced activities. Directs activities of direct reports as applicable. Participates in department or cross-functional initiatives as appropriate. DM/Study Tasks: Represents CDM in study team meetings. Manages CDM timelines to coordinate and synchronize deliverables with the overall study timelines. Generates and/or reviews/approves study documents (e.g. study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, coding conventions). Oversight of CDM CRO/service providers (e.g. reviewing vendor SOPs, invoices). Monitors the progress of all CDM activities for the project to ensure project timelines are met. Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, and able to work independently towards the assigned goal. Performs duties as assigned by CDM management/Head of Department. Qualifications: Bachelor’s, or master’s degree (preferred) in Life Sciences, Computer Sciences, Mathematics, or health-related field. Minimum ten (10) years of DM experience in the pharmaceutical or biotechnology industry. Three (3) year of staff management desired. Demonstrated ability to pay attention to details and superior organizational skills. CRO management experience. In-depth knowledge of CDM principles, clinical trial process and regulatory requirements. Excellent verbal/written and interpersonal skills; able to communicate and collaborate effectively with cross-functional teams in a remote setting. Good working knowledge of ICH, FDA, and GCP regulations and guidelines. Proven ability to work both independently and in a team setting. Experience with web-based Electronic Data Capture (EDC) preferably Medidata Rave, clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug. Prior oncology/hematology experience highly desirable. Ability to work in a team or independently as required. Outstanding organizational skills with the ability to prioritize. Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment. Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization. Flexible and willing to learn; adapting to business and site needs in a dynamic environment. Maintain a positive, approachable and professional attitude.

Requirements

Bachelor’s, or master’s degree (preferred) in Life Sciences, Computer Sciences, Mathematics, or health-related field.
Minimum ten (10) years of DM experience in the pharmaceutical or biotechnology industry.
Demonstrated ability to pay attention to details and superior organizational skills.
CRO management experience.
In-depth knowledge of CDM principles, clinical trial process and regulatory requirements.
Excellent verbal/written and interpersonal skills; able to communicate and collaborate effectively with cross-functional teams in a remote setting.
Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
Proven ability to work both independently and in a team setting.
Experience with web-based Electronic Data Capture (EDC) preferably Medidata Rave, clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
Ability to work in a team or independently as required.
Outstanding organizational skills with the ability to prioritize.
Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
Maintain a positive, approachable and professional attitude.

Nice To Haves

Three (3) year of staff management desired.
Prior oncology/hematology experience highly desirable.

Responsibilities

Responsible for timelines and quality of CDM deliverables for the assigned studies.
Contributes to technical infrastructure of CDM such as not but limited to development of SOPs, departmental process improvement etc.
Provides feedback and task assignment to meet department and company objectives.
Supports budget and resource planning across assigned projects as required.
Participates in CRO/vendor selection process for outsourced activities.
Directs activities of direct reports as applicable.
Participates in department or cross-functional initiatives as appropriate.
Represents CDM in study team meetings.
Manages CDM timelines to coordinate and synchronize deliverables with the overall study timelines.
Generates and/or reviews/approves study documents (e.g. study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, coding conventions).
Oversight of CDM CRO/service providers (e.g. reviewing vendor SOPs, invoices).
Monitors the progress of all CDM activities for the project to ensure project timelines are met.
Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, and able to work independently towards the assigned goal.
Performs duties as assigned by CDM management/Head of Department.