UNIV - Research Data Core Program Manager - Hollings Cancer Center

Job Description Summary
Reports up to the CTO Asst. Director for Clinical Activities. Primary responsibilities include the unit development of a centralized data core. Responsible for providing the HR oversight of the team by directly managing the lead data coordinators and research specialists. Serves within the CTO management leadership team and provides insight and support of CTO strategic initiatives.

Entity
Medical University of South Carolina (MUSC - Univ)

Worker Type
Employee

Worker Sub-Type
Classified

Cost Center
CC001332 HCC CTO Administration

Pay Rate Type
Salary

Pay Grade
University-07

Pay Range
56,210.00 - 80,105.00 - 104,000.000

Scheduled Weekly Hours
40

Work Shift

Job Description

35%Unit Development and Strategic Planning: In collaboration with the CTO managers, this position will support the identification and implementation of new initiatives to streamline and increase efficiencies of data management activities. This position will help develop strategic plans for the creation of a centralized data management core within the CTO. This may involve the creation and maintenance of new training and process guides for data management and implementation of corrective action plans related to data underperformance or deficiencies. They will participate in staff training, new employee orientation and education regarding data management. Works effectively and cooperatively with colleagues, assists with audits and routine monitor visits and collaborates closely with the AD of Clinical Activities and Quality Assurance and Education unit in the ongoing develop of data management processes. Will review data management performance metrics and proposed new initiatives to leadership.

30% Implementation of New Data Initiatives: Oversees the start-up and daily operations of the CTO Processing Lab including lab equipment acquisition, maintenance, SOP drafting/implementation, acquisition of Slope for tracking of specimen handling and kit inventory, oversight of physical lab space and assurance of OSHA and regulatory requirements with collaboration of MUSC Risk Management and the Principal Investigator. The PM1 will be responsible for the CTO Processing Lab in-servicing in start-up IAP2, ensuring the study has been built into Slope for Kit Inventory and Sample Management. The PM1 will participate in Resource Allocation and Feasibility Team (RAFT) to provide timely operational trial assessments in regard to data management and collaborate with ancillary services for quality assurance of clinical operations documents.

25% HR Team Management, Training and Mentorship of Clinical Operations Staff: Knowledgeable of local policies and procedures within Hollings CTO, University Compliance, and Institutional Review Board in addition to applicable Code of Federal Regulations and ICH Good Clinical Practice Guidelines. Responsible for recruiting, hiring, supervision, and effective evaluation of all clinical operations study coordination and data management staff within their DFGs. Understanding that selecting a job applicant who best fits the job requirements is paramount, the PM1 is still diligent about filling team vacancies in a timely manner to avoid extended periods of staff coverage. Works with the CTO management and the PCII of their team to ensure proper training of new and existing staff members. Mentors the PCII for developing new skills in clinical operations and team building. May assist the PCII in weekly preparation meetings with clinical staff to ensure that trial start-up, accrual, and study patient management are completed effectively. Listens for process improvement opportunities to train/re-train staff. Will help lead the team’s prioritization of work activities and coach the team in addressing obstacles to high performance. Rounds with physicians, ancillary services, and other external partners to gain feedback of employee performance. Stays abreast of protocol deviations or patient safety events and works closely with the CTO Asst. Directors to identify corrective action plans. Professionally communicates and discusses process improvement opportunities with staff or other stakeholders. If there are individual staff performance concerns, this role will collaborate with the Asst. Director of QAE and the CTO HR/business manager to coach and mentor the staff member and if needed, implement a personal improvement plans per MUSC HR policies. Develops and participates in the formal departmental orientation programs and development and maintenance of a clinical operation employee manual. Works in conjunction with the CTO HR Mgr. to provide updated position descriptions for position postings, conducts candidate interviews and selection. Completes evaluation(s) on the Success Factor’s system based on employee's actual duties and sets the success criteria for annual rating. Prior to the end of the rating period, the PM1, with the PCII, will conduct staff performance evaluation meetings to provide feedback and help employees grow professionally

10% CTO Strategic Planning and Other duties as assigned: Assess employee workload and propose and implement staffing plans to meet trial performance needs. Contribute in CTO Management meetings, HCC Clinical Investigations meetings and other meetings as assigned. Professionally communicate to staff and ancillary group and other related external partners the missions and goals of the HCC CTO to promote buy-in and engagement. Helps oversee that team is following CTO procedures for data and task entries into CTO systems such as the CTMS (OnCore) which populate reporting of trial performance metrics. Establishes corrective action plans with staff should there be issues with performance metric data entry. Thus, a working knowledge of the IT systems and other related policies is required. Assists the CTO Director with special projects and duties to help carry out new initiatives or process improvement pilots. May help with special coverage of CTO activities.

MUSC Minimum Training and Experience Requirements:

A bachelor's degree andthree yearsrelevant program experience.

Additional Job Description
Minimum Requirements: A bachelor's degree and three years relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to match or discriminate between colors. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

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