Actelion Clinical Research, Inc. is the clinical development headquarters for the Americas of Actelion Pharmaceuticals Ltd., one of the most successful biopharmaceutical companies in the world today.  While our corporate headquarters are based in Allschwil, Switzerland, ACR offices are conveniently located in Cherry Hill, New Jersey, just outside of Philadelphia.

POSITION SUMMARY

The Operations Manager provides leadership to the Operations team (internal and regional) by creating an environment that enhances cooperation, trust, learning and calculated risk taking.  This position supports the Clinical Development objectives and related regional activities using strong management, leadership and organizational skills.  The Operations Manager will manage and direct the efforts of the Operations Group to ensure the effective planning, oversight, and coordination of projects regionally.  This includes allocating regional resources in alignment with the project needs, directly managing Operations personnel not assigned to an OPL (recruitment, hiring, performance management, training and development, etc.) and providing strong leadership, guidance, coaching and feedback to promote development of team members. 

PRIMARY RESPONSIBILITIES

Product/Program Level:

·        Accountable for meeting regional objectives/deliverables across projects for studies not lead from the Americas

·        Allocate regional resource needs across projects

·        Identify potential operational problems, issues, obstacles and barriers across all projects based on feedback and effectively mitigate them or report them to appropriate Clinical Operations Product Lead (COPL) for handling

·        Support the product/program team and COPL in meeting overall product/program timelines

·        Negotiate, resolve conflicts and escalate issues to the Head of Global Clinical Operations Americas

Multidisciplinary Group Management:

·        Participate and support efforts to develop and implement global process/system improvements

·        Maintain open communications with the Medical Directors in the Americas on clinical activites/projects

People Management:

·        Establish accurate and consistent productivity expectations and revise as needed.  Make recommendations regarding staffing requirements to meet regaional needs and achieve maximum productivity

·        Define and communicate job description, core competencies, performance standards and expectations

·        Perform appraisals and set objectives annually

·        Implement orientation and training programs for new employees

·        Provide ongoing training, continuing education, and professional development for internal Operations personnel

·        Develop and implement reward and recognition programs to achieve optimal employee satisfaction and retention

·        Recognize high performing teams and individuals

·        Review and approve expense reports, training, travel, and time off requests

Quality:

·        Share best practices and promote sharing of best practices across Global Opertions

·        Ensure team members are following Actelion SOPs, ICH guidelines, GCP, and local regulatory requirements

·        Provide input into SOPs and global processes

·        Review/modify existing processes to eliminate non-value work and implement new processes to enhance team performance and expedite results without compromising data quality

·        Coordinate regular staff meetings and ensure Internal Operations personnel are kept abreast of departmental and organizational activities, goals and policies

Develop Others:

·        Exemplify strong leadership and provide guidance, coach and feed back to promote development of team members

·        Provide feedback to team member on team member performance, thus helping to develop each team member

·        Act as mentor and subject matter expert for team members

·        Encourage team members to meet stretch goals

·        Encourage team member to try new approaches and take risks

Financial Responsibilities and Accountability:

·        Prepare budgetary forecast for the Operations Group expenses (operating and capital) on an annual basis

·        Monitor expenditure of the Internal Operation budget monthly and provide justification of variances to Global Head of Clinical Operations

·        Monitor expenditure of funds relative to monthly budgetary projections for all projects/studies done regionally

·        Demonstrates overall cost consciousness

 SUPERVISORY RESPONSIBILITIES

·        Manage CTPMs, CTMs, CRAs, and CTAs and Documentation Manager

QUALIFICATIONS

·        Bachelor’s degree in biological science, nursing or other science-related field

·        At least 8 years of pharmaceutical industry experience with at least five years experience leading clinical trials globally

·        Thorough knowledge of CRF, ICH, and GCP guidelines including internal regulatory requirements for the conduct of clinical development programs

·        Prior line management responsibility

·        Strong project management skills

·        Highly effective communication, interpersonal and leadership skills

·        Ability to effectively influence, negotiate, and problem solve

·        Prior experience with providing direction, motivating and driving the performance of direct reports

·        Demonstrated computer skills

·        Domestic and international travel required

What Actelion Offers

Actelion offers its employees a unique culture based on the core values of innovation, trust and teamwork, open communication and results orientation.  Our employees enjoy an innovative and stimulating atmosphere within a multicultural environment.  Actelion offers the opportunity to impact the lives of patients in a positive way.  Our employees are key to our success.

Actelion is an equal opportunity employer.