Clinical Research Project Manager B / C

Clinical Research Project Manager B / C

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.

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. 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.

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

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.

Philadelphia, Pennsylvania

Perelman School of Medicine

$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.

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition : Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
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• Time Away from Work : Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with familywhatever your personal needs may be.
• Long-Term Care Insurance : In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
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• Professional and Personal