Clinical Trial Manager Functional Manager - Infectious Diseases & Vaccines Job

Job description

Clinical Trial Manager Functional Manager
- Infectious Diseases & Vaccines-000012IYDescriptionJanssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Trial Manager Functional Manager
- Infectious Diseases & Vaccines, located preferably at a J&J site in North America, such as Raritan, NJ or other J&J sites such as Titusville NJ, Springhouse PA, Canada, or European site locations preferably in United Kingdom, Beerse Belgium, Leiden Netherlands.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.
JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Clinical Trial Manager Functional Manager will provide operational leadership to a team of Clinical Trial Managers within GCDO, driving the study placement and country/site management activities within an assigned Therapeutic Area. He/she is responsible to ensure all trials are timely and appropriately staffed for the assigned TA, and oversees that studies are carried out within agreed timelines and in line with all the applicable SOPs and regulatory requirements.
This position is responsible for the functional management of a team of Clinical Trial Managers, overseeing staff development, project assignments, workload distribution, and issue resolution with direct reports. He/she ensures alignment of goals with organizational objectives and assigned trial objectives as defined in the GC(D)O local goals and objectives.
The CTM Functional Manager may act as the business owner for assigned processes and/or support continuous process improvements. This position influences Clinical Trial Management decisions as appropriate and understands and aligns with long-term business needs.
This position makes decisions and recommendations that will have a direct impact on resource allocation and the success of the trial delivery.
The individual is responsible for, but not limited to the following:Provide operational leadership over a team of CTMs and the projects they manage:Lead the CTM team so that execution of clinical trials is done according to required timelines and according to protocol, International Guidelines for Good Clinical Practice, international and national SOPs and local procedures and regulations.
Ensure a strong connection to the country teams is built in every trial, and that local as well as global perspectives are incorporated in the trial setup.
Oversee resource allocation for assigned TA portfolio. Establish and manage resource allocation within team, oversee workload of the staff to ensure optimal utilization of resources.
Set operational objectives for his/her team and ensures alignment with company, project team, departmental objectives.
Develop strong working relationships with key business partners, and create a culture of cross-functional collaboration across all teams:Works effectively with GCO Regional/country Heads and business support groups as well as Portfolio Delivery Operations, Quality Management, IDAR, Regulatory, Clinical Supply Chain and Q&C.Align with the respective GCDO Operations Head and GCDO Program Leaders.
Build a high performing team through on-going development, performance management and coaching. Take ownership for ensuring a strong pipeline of leaders within the organization through the Succession Planning process, and foster employee engagement, inclusion and Credo Behaviors.
Lead/support improvement opportunities across clinical operations, and provide leadership for the development and implementation of innovative business practices and improved business processes.
Lead the effective and timely resolution of issues escalated by the countries or site facing vendors. Provide clear feedback on performance of vendors interfacing with CTMs and propose mitigations.
Strong interaction with the PDO, GCO, Central Support Groups, IDAR, Clinical Supplies Unit (CSU), Q&C and external vendor groups.
QualificationsA minimum of a Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy),Minimum of 8 or more years of clinical trial management experience or combination of clinical trial related experience, in the pharmaceutical industry or CRO.Requires clinical research operational knowledge, project planning/management and communication skills. Flexibility and ability in managing global or regional teams in a virtual environment is required.
Demonstrated experience managing or mentoring clinical operations team members is required.
Effective leadership skills and proven ability to foster team productivity and cohesiveness is required.
Experience with CRO and vendor management and oversight is preferred.
Specific therapeutic area (Infectious Diseases & Vaccines) experience is strongly preferred.
Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
Computer literacy is also required.
Willingness to travel as needed based on team.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NAPrimary Location:North America-United States-New Jersey-RaritanOther Locations:Europe/Middle East/Africa-Belgium, North America-United States, Europe/Middle East/Africa-Netherlands, North America-United States-Pennsylvania-Spring House, North America-Canada, Europe/Middle East/Africa-United Kingdom, North America-United States-New Jersey-TitusvilleOrganization: Janssen Research & Development, LLC. (6084)Job Function: Clinical Trial AdministrationCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement