Principal Clinical Trial Manager

Summit, NJ US
Competitive Salary
Oct 04, 2016
Nov 01, 2016
Result Type
Position Type
Full Time


Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.


The Principal Clinical Trial Manager provides leadership and oversight of the clinical research program(s) to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs.  Responsibilities include providing strategic operational direction, execution of complex study(ies) and/or oversight of multiple cross-functional study team(s) and performance and quality oversight of the associated Contract Research Organization (CRO) teams. They should be able deliver high caliber  presentations to senior and executive leadership within and outside of Celgene (as appropriate). The Principal clinical trial manager is expected to consistently demonstrate  strategic critical thinking skills for problem solving and have the lateral and insightful thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.

The Principal clinical trial manager has overall accountability for the execution of the Clinical Operations strategy for the program(s)  and /or studies which may include but is not limited to the following:

Program Management

·          Provision of guidance on operational program implementation and management

·          Accountable for ensuring that program-specific standards are developed and applied  across trials  [in line with portfolio-level standards] to ensure consistency and efficiency

·          Driving the operational program strategy in close interaction with CRO partners

·          Active contribution to the scientific and operational feasibility as well as oversight and alignment of activities of the internal and external operational team members contributing to the program

·          Reports to senior management as needed with regards to all matters of clinical program implementation

·          Leading/driving collaboration with CRO partner(s) for program operational delivery to ensure meeting expected timelines, budget, and quality in alignment with Celgene expectations and standards

·          May represent Clinical Operations within the global project team



Financial Planning and Project Management

·          Drive the early planning of study / program timelines and budgets through close collaboration with other functions (e.g. Clinical, Clinical Trial Analytics, PSRM, Finance, Data Management, IMSC and other relevant functions)

·          Takes ownership and accountability for development and management of study and/or program level budgets

·          Collaborate closely with Project Leadership to ensure that timelines and budgets are appropriately presented to governance committees.

·          Notify Clinical Trial Management Leadership (and other relevant functions) of resource requirements for new studies

·          Support identification and resolution of issues related to study timelines and budgets

·          Lead regular (e.g. quarterly) program budget review meetings with Finance and ensure that anticipated budget deviations are flagged.

·          Review study planning and tracking tools regularly (including study budgets), flag deviations to relevant stakeholders and develop mitigation plans in collaboration with Clinical  Trial Managers and other relevant functions

·          Development/management/reconciliation of overall program budget(s) or oversight thereof

·          Development/management/reconciliation of CRO partner scope of work (SOW) per contract, quality, and budget 

·          Oversight of review/approval of clinical service provider (vendor) invoices and management of accruals and SOW changes.

·          Oversight of program execution utilizing available performance metrics and quality indicators

·          Oversight of development  and management of key program milestones and deliverables  through collaboration with  internal and external stakeholders

·          Proactive identification/assessment of potential risks at program level and oversight of development/implementation of actions to avoid or mitigate

·          Oversight of the maintenance/updating of data as appropriate in study management tools including CTMS

·          Informing leadership (as appropriate) on overall clinical program progress, updated forecasting, and of potential issues/mitigation

·          Excellence in identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs.


Program Planning and Conduct

·          Operational input into program and study level planning and documents as appropriate

·          Development [in collaboration with CRO partner] of innovative clinical operation strategies (such as patient access, recruitment, and retention) at the program  level

·          Oversight of clinical service provider (vendor) selection, specification development, and management.

·          Oversight of development/implementation of program-specific training for program/study teams, investigational sites, and vendors


Relationship Management

·          Development/maintenance of collaborative relationships with:

o    internal partners/stakeholders including Clinical Research, CR&D Operations, Affiliates and Project Management

o   external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers

Continuous Improvement


·          Collaborate with colleagues within Clinical Operations and from other Departments to maximize efficiencies, share and apply best practices

·          Flag potential process improvement opportunities and support execution

·          Expected to lead continuous improvement or other departments or cross-functional initiatives.

Line management

·          May be responsible for oversight of one or more contract Clinical Trial Managers

Organizational Impact

•    Operational direction and oversight of multiple cross-functional study and program team(s) and performance and quality oversight of the associated Contract Research Organization (CRO) teams


•    Ensures delivery on corporate objectives and drives goals

•    High global organizational impact and influence within and across programs

•    Leads large/complex global cross functional therapeutic programs

•    Exemplifies strong leadership and provides mentoring and guidance within and across teams to promote development of team members.

•    Corporate functional integration / team building (global)

Develops and oversees program team members – Acts in the capacity of line management/may have direct reports


•    Fully independent

•    Leads one or more complex, large , global program(s)

•    Effectively multi-tasks and sets priorities for self and assists other program team members in same

•    Mentors and trains program team members

•    Line management/ may have direct reports  

•    Oversees service providers at program level without supervision

Creativity and Problem Solving

•    Highly proactive program-level risk identification, contingency planning, and innovative problem solving

•    Proficiency in solving complex problems for multiple functions

•    Proactively identifies interdependencies, links, and opportunities for effective and creative problem solving

•    Provides strategic input to program team(s)

•    Identifies/presents issues and solutions to senior management

•    Provides guidance to program team members

•    Ensures sharing of ‘lessons learned’ within and across programs and functions

Teamwork/Influence (Scope of Communication

•    Program team driver and motivator in challenging times

•    Motivates and holds others accountable for accomplishing goals

•    Holds self accountable, setting an example for others to follow

•    Excellent negotiating and global/cross-functional influencing skills

•    Models and promotes highly collaborative team behaviors in a global cross-functional atmosphere within/across Celgene/CRO team(s)

•    Builds a culture of energy and commitment that challenges people to excel

•    Provides guidance / feedback on performance

•    Team arbitrator, trouble shooter at program level

•    Evaluates and provides feedback on global considerations across program teams

•    Influences key stakeholders outside of the program team and capitalizes on established relationships / networks

•    Leads, develops and implements cross-functional/global initiatives and best practices

•    Recognizes and rewards team accomplishments

•    Recognized as SME by cross functional Celgene/CRO teams

May participate in the clinical development team

Functional Scientific/Technical Skills

•    Strategic expert of program and study management

•    Expert knowledge Clinical Trial Process (CTP) and drug development process

•    Expert project management skills Expert knowledge of GCP/ICH and guidelines, regulations and directives

•    Excellent oral and written skills and ability to effectively apply these skills

•    Expert in computer technical skills, competency for current level

•    Expert knowledge of clinical trial budgeting, forecasting, and financial management.

•    Develops clinical program independently

•    Expert level cross functional awareness

Expert in communication / mentoring 



·           Skills/Knowledge Required:

·          Recognized as a technical Expert in the operational execution of the studies

·          Clinical trial project management skills

·          Financial budgeting and forecasting skills

·          Leadership / influence management  skills

·          In depth knowledge of ICH/GCP, regulatory guidelines/directives, and clinical research processes

·          Disease/Therapeutic knowledge and expertise is highly desirable

·          Comprehensive expertise in drug development, including solid knowledge of interfaces and interdependencies of clinical development with other functions (e.g. nonclinical & pharmaceutical development,  regulatory,  commercial/marketing)

·          Solid Therapeutic Drug Development expertise for the assigned program

·          Understanding of cross-functional components of the operationalization of trials to integrate input from internal and external team members into the clinical operation strategy

·          Ability to lead a global, cross-functional virtual team

·          Ability to lead and drive program planning and delivery in collaboration with CRO partners

·          Time management skills – ability to effectively multi-task and prioritize

·          Proven problem-solving skills to prevent and overcome complex safety and compliance related issues during clinical program implementation and execution

·          Demonstrated success in using oral and written communication skills to influence, inform, or guide others

·          Solid computer skills – requirement of MS applications including (but not limited to) MS Project, Word, Excel

·          Study Tools including electronic system skills – CTMS / EDC

Key Leadership Competencies:


§   Creates realistic plans that clearly define goals, milestones, responsibilities and results

§   Maintains focus on strategic objectives while accomplishing operational goals

§   Places a priority on getting results with an emphasis on high quality outcomes

§   Holds self and others accountable for accomplishing goals

§   Makes timely, data-driven decisions

§   Develops and maintains effective working relationships with people across cultures

§   Encourages and supports collaboration across teams, functions, and geographies

§   Ensures that conflict is handled constructively so that performance is not impacted

§   Displays a willingness to challenge the status quo and take risks

§   Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute

Maintains optimism and composure in times of  change, uncertainty, or stress

Education and Experience Guidelines

•    BA / BS, Advanced degree preferred

•    Degree in relevant discipline

•    Minimum of 10 years clinical research experience including all aspects of clinical trial planning and start up (including budget & resource planning), and in executing a wide range of clinical trial activities, from start up through final study report

•    At least 6 years clinical study management experience with

•    At least 4 years direct multinational study management experience

•    Minimum of 4 years experience in oversight of CRO study execution

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.