Senior Clinical Program Manager

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Oct 06, 2020
Ref
R-123685
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Position Purpose:

The Senior Clinical Program Manager (Senior CPM) is accountable for the development of the operational strategy for a clinical program as well as the on-time delivery of a clinical program and remaining within budget for an assigned Therapeutic Area.
  • Responsible for clinical operational planning activities and is accountable for leading program/study execution.
  • Manages two or more studies/or products and may take on additional responsibilities as defined by the Therapeutic Area Lead as dictated by project size and complexity with minimal oversight.
  • Leads overall clinical project management, leads, supports, and advises the cross-functional study execution team (SET) and coordinates study execution at the global level.
  • Oversees program/study level outsourcing, takes preventive/corrective action(s) to address study/program level issues.
  • Manage/mentor Clinical Study Managers (CSMs) and Clinical Trial Assistants (CTAs).


Main Responsibilities and Accountabilities:

Plan, manage and execute clinical programs

• Responsible for the project management of a clinical program/study

• Participate in program resourcing discussions

• Create and drive study level timeline

• Develop overall feasibility concept and enrollment plan with input from site management team

• Develop and manage study budget

• Provide input on operational aspects of the protocol

• Ensure regulatory compliance and GCP compliance

• Responsible for oversight of TMF with periodic audits

• Responsible for leading vendor selection and management including issue escalation

• Develop and implement Study Management plan and all associated documents (i.e. vendor oversight plan)

• Collaborate with CTS team to plan and coordinate IMP and non-IMP supplies

• Plan, lead, and facilitate SET (internal) meetings as well as act as the CSL lead for vendor meetings

• Ensure monitoring plan is developed and consistently executed in collaboration with COMs

• Develop proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs

• Consults with site management team for strategic selection of countries and sites

• Facilitate and coordinate communications with external provider

• Ensure Clinical Operations team and external provider receive study specific training

• Report key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality

• Facilitate study close out activities through completion of Clinical Study Report

• Provide operational input into the overall program strategy.

• Act as the primary point of contact for internal groups outside of CRD (including Regulatory, Commercial Development and Project Management) for program/study specific information.

• Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations.

• Ensure standard processes, tools and procedures are used consistently for study execution.

Position Qualifications and Experience Requirements:

Education

At minimum, bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.

Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).

Experience

Essential Experience

• As a guide, a minimum of 10+ years' project management of Phase I-III clinical research experience within the pharmaceutical industry.

• A solid understanding of the drug development process, and specifically, each step within the clinical trial process.

• Experience in overseeing global clinical trials (pharmaceutical or research institute).

• Budget forecasting and management.

• Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.

Desired Attributes:

• Postgraduate qualifications.

• Experience in scientific/medical research.

• Specialist knowledge e.g. immunology, coagulation disorders, pulmonology, virology, oncology and cardiology.

• Demonstrated proficiency in advanced MS Project. Competencies

• Demonstrated ability to lead teams and work in a fast-paced team environment.

• Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment

• Demonstrated successfully the ability to mentor and coach others through peer to peer interactions

• Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy and enthusiasm to deliver the program objectives.

• Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.

• Ability to plan, and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.

• Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.

• Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains current medical/scientific/regulatory knowledge.

• Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.

• Demonstrated ability to problem solve and use clear judgment in relation to interactions with external parties, timelines, and complex clinical programs.

• Excellent written and oral communication skills.

• Maintains computer literacy in appropriate software.