"Clinical Research Project Manager B/C"

Job Description Summary
The primary purpose of this position is to manage and oversee renal clinical research trials, specifically transplant and hypertension research portfolio ranging from observational and interventional phase I to IV trials, investigator initiated and industry sponsored trials that involve different disease states of varying complexities. Clinical Research Project Manager will provide expertise related to these trials, staff oversight, project management and leadership. The position involves planning, designing and overseeing the daily operations of the staff in order to successfully execute and operate the above research protocols (regulatory submissions and development of key study documents including protocol, consent, and CRFs) in accordance with all the regulatory organizations and sponsors, while maintaining best practices and procedures. He/She will work closely with the investigators and devise recruitment and retention strategies, and workflows for various studies to ensure enrollment goals are met. The position involves working closely with the pathology departments of multiple hospitals, and interact with other research institutions, industry sponsors and the NIAID to achieve the objectives of complex multi-center studies.

Job Responsibilities
The position involves assessing the feasibility and performing the operational analysis of the novel research protocols, and conducting the startup work for these protocols by working closely with the business administration. He/She is responsible for overseeing the financial health of hypertension and transplant research protocols, facilitating the negotiations with the sponsors, and collaborate with the business administration for billing and invoicing activities. The Clinical Research Project Manager will provide staff oversight, project management, leadership and expertise associated with clinical trials for the Renal Clinical Research Unit consisting of projects in Transplant Nephrology and Hypertension.
For Clinical Research Project Manager B: Will provide expertise related to these trials, staff oversight, project management and leadership. The position involves planning, designing and overseeing the daily operations of the staff in order to successfully execute and operate the above research protocols (regulatory submissions and development of key study documents including protocol, consent, and CRFs) in accordance with all the regulatory organizations and sponsors, while maintaining the best practices and procedures. He/She will work closely with the investigators and devise recruitment and retention strategies, and workflows for glomerular studies including the rare disease studies that are difficult to recruit. The position involves working closely with the pathology departments of multiple hospitals, and interact with other research institutions, industry sponsors and the NIAID to achieve the objectives of complex multi-center renal studies. The position involves assessing the feasibility and performing the operational analysis of the novel research protocols, conducting the startup work for these protocols by working closely with the business administration. He/She is responsible for overseeing the financial health of renal research protocols, facilitating the negotiations with the sponsors, and collaborate with the business administration for billing and invoicing activities. S/he will oversee expenditures and income, negotiate agreements with service providers, and interact with the business administration to ensure income is received and expenditures are paid. The position will also include participation in national organization meetings, as well as University department meetings and committees. The staff member will maintain skill levels through educational opportunities, sponsor trainings, attendance at conferences and communication with other providers.
For Clinical Research Project Manager C: The position will oversee the daily operations of the unit working closely with other leadership to support the program's clinical research portfolio. The Clinical Research Project Manager is responsible for project development and oversight, staff management, and operational effectiveness of the unit. The candidate will manage relationships between physicians, sponsors, other academic centers, staff, and administrative offices. The Clinical Research Project Manager will lead operational planning relating to the research activities and ensure optimal communication across stakeholders. The Clinical Research Project Manager will support grant development, participate in facility and contractual issues, and may participate in budget development and management. Responsibilities will also include developing and measuring programmatic metrics for efficient process planning and financial management for assigned projects, and will include reporting on those metrics and implementing innovative approaches to further expand the unit with operationally and financially successful research collaborations and projects. Additional duties will include developing innovative ways to communicate research-related information, education and news across the unit. The Clinical Research Project Manager role will focus more heavily on Staff Management and Development and Program Leadership.
Other duties and responsibilities as assigned.

Qualifications
Strong planning and organizational capabilities along with attention to detail, excellent follow through and problem solving skills necessary. Strong staff management skills required. Must be effective in setting and meeting personal short and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously. Successful candidates will have the ability to anticipate problems relating to projects and to develop and implement solutions. Flexibility and the drive to meet project deadlines required. Knowledge of regulatory processes required. Excellent written and verbal skills required. Position contingent upon funding. Must show progressively responsible project management and supervisory experience, preferably in an academic institution managing clinical research projects, as well as demonstrated leadership of complex projects. Must show ability to work with multiple stakeholders to coordinate and achieve goals, and form strong business relationships with collaborators. Must be effective in setting and meeting personal short and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously. Successful candidates will have the ability to anticipate problems relating to projects and to develop and implement solutions, as well as handling complex problems related to business strategy. Significant experience with developing and implementing processes and operations strongly preferred, as well as with SOPs and other training tools. Flexibility and drive to meet project deadlines required. Strong innovative skills preferred. Excellent interpersonal and multi-tasking skills required. Excellent verbal/written communication skills required. Able to confidently interact with all levels of management including senior management, physician leaders and others. Thorough knowledge of relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines. Knowledge of funding policies, NIH, and other grant procedures is desired.
Clinical Research Project Manager B - Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required. Master's degree and 3-5 years of experience preferred.
Clinical Research Project Manager C - Bachelor's Degree with 7-10 years of related experience or equivalent combination of education and experience is required. Master's degree and 5-7 years of experience preferred.

Pay Range
$74,500.00 - $115,000.00 Annual Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.