Share this Job
Email similar jobs to meEmail similar jobs to me

Senior Clinical Operations Manager (m/f) Job

Date: Nov 9, 2017

Location: Haar, BY, DE

Company: MSD

Requisition ID: CLI006137

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


For our Global Clinical Trial Organisation (GCTO) in Haar near Munich we are looking for a highly motivated and qualified

Senior Clinical Operations Manager (m/f)

The position is office based.

This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, MSD policies and procedures and with quality standards internally and externally.

The person has ownership, oversight and impact on local regulatory and financial compliance and for out-tasking as applicable. Under the oversight of the Clinical Research Director (CRD) the person is responsible to manage a team of 6-14 Clinical Operation Managers or Clinical Trial Coordinators.

Responsibilities include, but are not limited to:



  • Has significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up:

  • FINANCIAL:
    o Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
    o Interacts successfully with local clinical team/s in order to deliver clinical and financial contracts within fair market value. Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. Financial forecasting and tracking of operational budget in conjunction with CRD.

  • COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS:
    o Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols, development of local language materials including local language Informed Consents and translations.
    o Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

  • MANAGEMENT & QUALITY OVERSIGHT:
    o Responsible for managing country deliverables, timelines and results in assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to development of local/Int'l SOPs.
    o Oversees CTCs and contract workers (e.g. CTCs) and local vendors and may manage COMs, both as applicable.

  • COLLABORATION:
    o Works with minimal oversight from CRD in close collaboration internally with GCTO Country Operations (CRM, CTC, CRA, COM and CQM), Medical Affairs, PV, Regulatory Affairs, Business Compliance, MRL/Local finance departments, legal, HQ functional areas and externally with vendors and sites to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
    o Collaborates closely with Regional Operations to align country timelines for assigned protocols.
    o Provides support and oversight to local vendors as applicable.

  • LOCAL PROCESS OVERSIGHT:
    o Oversight and coordination of local processes; clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, insurance process management.
    o Enters and updates country information in clinical, regulatory, safety and finance systems.
Qualifications

 



  • 8-10 years of experience in clinical research

  • Master's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

  • Fluency in both English and German

  • Demonstrates proactive leadership and must be able to in/directly influence investigators, vendors, external partners and country managers to deliver these commitments within specified timelines and budgets, with minimal oversight from the CRD.

  • Skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment and submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.

  • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the pros and cons of each decision and takes ownership of decisions

  • Extensive experience with clinical project management and coordination

  • Expertise of core clinical, regulatory and financial systems, tools and metrics

  • Extensive knowledge of local regulatory environment and submission and approval processes

  • Strong coordination and organizational skills

  • Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures

  • Demonstrates leadership behaviours

  • Problem solving and Process Improvement is essential to this position.

  • Ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones

  • Strong communication and leadership skills

  • Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal

  • People management skills (also across countries) will be valued

  • Ability to focus on multiple deliverables and protocols simultaneously is essential

  • Ability to work effectively also in a remote virtual environment with a wide range of people and understanding of cultural differences


We are looking forward to receiving your application (CV and application letter) in English.

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.



Job: Clinical Research - Clin Ops
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Clinic, Operations Manager, Medical, Law, Healthcare, Operations, Legal